OriGen Biomedical Open Jobs

POSITION SUMMARY

The Clinical Specialist plays a pivotal role at the intersection of sales, marketing, regulatory affairs, engineering, and quality affairs within our organization. Reporting directly to the Director of Global Business Development, this position serves as a crucial liaison with various departments including Regulatory, Quality, Engineering, Customer Service, and Marketing at our corporate offices in Austin, TX.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential duties and responsibilities of this position include, but are not limited to the following:

• Develop a broad-based technical capability at OriGen to gain knowledge and experience in the applications of our products to enable us to better inform our customers about their proper use
• Ability to create and deliver presentations to customers online and in person as required
• Act as technical liaison for information transfer between customers and appropriate OriGen Departments. Example Sales, Engineering, Production, QA/RA, Marketing
  • This includes but is not limited to technical input on current or future design and development projects
• Participate in the development of an educational curriculum for OriGen
• This will include but is not limited to online education, in-house seminars, regional training at other locations, as well as technical presentations and workshops at various professional association meetings
• To assist in the preparation of technical/clinical articles on various OriGen products and techniques for publication
• To interact and provide technical support to internal Stakeholders
• Provide education and training to internal Stakeholders
• Assist customers in the clinical environment by educating, directing care, or assisting with applications of our products and techniques
• Assist with strategic customer visits

REQUIRED SKILLSETS

• Must be detail-oriented
• Must be proficient on a computer, possessing advanced navigation and program knowledge

COMPETENCIES

• Self-starter managing day-to-day tasks and working in collaboration to accomplish deadlines and objectives
• Interpersonal skills necessary for working effectively in a team environment
• Works cross-functionally to complete projects and testing
• Exercises judgment and makes sound decisions within broadly defined practices and policies
• High emotional intelligence and ability to navigate conflict and complex issues
• Problem-solver at all organizational levels – focused on what is best for OriGen
• Outstanding communication skills, both written and oral, in communicating across and outside of the organization
• Ability to actively listen, evaluate alternatives, and articulate options, thoughts, and ideas
• High personal and professional integrity and emotional maturity
• Able to accept positive and constructive feedback with grace, interest, and poise
• Strong ability to influence and persuade

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• 2+ years experience working with our products or similar
• 2+ years working in a cell therapy lab
• Bachelor’s degree in life sciences
• Knowledge of regulations and guidelines for medical device sales and marketing
• Demonstrated ability to use effective and results-oriented problem-solving and critical-thinking skills
• Strong ability to understand and interpret customer needs; customer-centric; ability to proactively work with diverse work teams
• Strong interpersonal and people skills
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Outstanding communication skills (verbal and written)
• Ability to work independently and within a team environment on assigned projects from inception to completion
• Knowledge of FDA regulations and guidelines for medical device process validation.
• Proven skills in coordinating and managing day-to-day tasks and working in collaboration to accomplish deadlines and objectives.
• Proficiency in technical and layman writing.
• Thrives in a team environment
• Proficiency in using computer software applications including Microsoft Office Suite, Salesforce, G-Suite, and Asana.
• High aptitude for learning new technical information, products, and their applications

PREFERRED QUALIFICATIONS

• Bachelor’s degree in Microbiology
• 5+ years’ experience working with our products or similar
• 5+ years working in a cell therapy lab

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities. However, it may require leading/reporting on projects and ensuring participants meet deadlines.

WORK ENVIRONMENT

This job operates in a climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The noise level in the work environment is generally moderate however periods of higher-level noise may occur.

This job may also operate in a cleanroom environment. The cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

• Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when required

PHYSICAL DEMANDS & WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand, walk, climb, sit, stoop, bend, and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds and may be required to operate automated warehouse equipment; e.g. electric pallet jack, or forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.

Travel

10-15%

Salary:

The Customer Service Representative II is responsible for primary customer contact.  They will be the first point of contact for customer service calls, emails, and fax;  they must remain friendly and courteous at all times. Candidate is expected to develop an understanding of the product lines and be able to quickly assist customers with requests.  A comprehensive understanding of OriGen Products isexpected.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

• The Customer Service Representative II will create new accounts, once approved.
• Assist the customer with technical information on product usage and help troubleshoot any issues that may

  arise for them.

• Handle entry of complaints, provide good faith follow up efforts when needed, and follow up with the

  customer at the completion of the complaint investigation to send the final complaint response letter.

• Candidate must have a friendly and courteous telephone persona, be able to take phone orders.
• Accurately transfer all orders sent via fax, email or take over the phone to our ERP system and follow up

  with the logistics team in the US and the Netherlands, if needed.

• Coordinate with Production for any products requiring a lead time and communicate that to the customer.
• Responsible for assisting customers with returns, and following up with Accounting to ensure that credit

  notes are sent or refunds issued.

• Issue both verbal and written quotes as needed.
• Liaise with the European Distribution Center to ensure that all information is handed off to them correctly.
• Careful organization of work and timely responses are required.
• Create sample shipments for customers when requested.
• Able to communicate in a positive manner.
• Ability to follow detailed written and verbal instructions.
• Trains team members on customer service processes.
• Ability to learn multiple tasks and train in other areas as needed.
• Ability to accurately perform job duties with minimum supervision.
• Ability to work in a multi-cultural team environment and be a team player.
• Ability to work in a cleanroom environment for extended periods of time.
• Be punctual and reliable.
• Other duties and/or projects as assigned.

REQUIRED SKILLSETS

• Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish

  deadlines and objectives.

• Knowledge and skill in using computer software and hardware applications, including Microsoft Word and

  Excel.

• Outstanding communication skills, both written and oral, and will be expected to communicate directly with

  customers, production management, production technicians, engineers, and senior management.

Competencies

• Results-driven
• Technical Capacity
• Ethical Conduct
• Communication
• Decision making
• Interpersonal skills
• Stress Management

Minimum Qualifications (Knowledge, Skills, and Abilities)

• High School Degree or GED
• 3+ years of related experience
• One year of customer service experience or equivalent
• Strong ability to understand and interpret customer needs
• Strong interpersonal and people skills
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Strong and effective communication skills (verbal and written)
• Pays very close attention to detail
• Ability to work independently and within a team environment on assigned projects from inception to completion

Preferred Qualifications

• Bachelor’s degree in a science or related field
• 5 + years of related experience
• Experience with Medical Devices or Regulatory environment

Supervisory Responsibility

This position has no supervisory responsibilities; however, the individual may be required to lead projects and ensure participants meet deadlines.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the work environment is usually moderate.

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail.

POSITION SUMMARY

The Post Market Surveillance (PMS) Associate is responsible for managing post-market surveillance activities, including handling complaints, conducting investigations, and ensuring compliance with regulatory requirements. The role involves analyzing data, preparing reports, and supporting continuous improvement efforts to enhance product safety and performance.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential duties and responsibilities of this position include, but are not limited to the following:

Complaint Management:

• Receive, document, and track customer complaints related to medical devices.
• Conduct thorough investigations of complaints to determine root cause and identify corrective actions.
• Ensure timely and accurate documentation of complaint investigations in accordance with regulatory requirements.

Post Market Surveillance:

• Support the development and implementation of post-market surveillance plans in compliance with relevant regulations (e.g., FDA, EU MDR).
• Collect and analyze post-market data from various sources, including customer feedback, clinical studies, and adverse event reports.
• Monitor and evaluate product performance and safety trends to identify potential issues.

Regulatory Reporting:

• Prepare and submit required regulatory reports (e.g., Medical Device Reports, Vigilance Reports) to appropriate authorities.
• Maintain up-to-date knowledge of global regulatory requirements related to post-market surveillance.

Cross-Functional Collaboration:

• Work closely with Engineering, Operations, Quality and Regulatory teams to ensure effective communication and resolution of post-market issues.
• Provide support during internal and external audits and inspections.

Continuous Improvement:

• Identify opportunities for process improvements and contribute to the development and implementation of corrective and preventive actions (CAPAs).
• Support quality improvement initiatives to enhance product safety, performance, and customer satisfaction.
• Execute other quality and regulatory tasks as instructed by management.

REQUIRED SKILLSETS

• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Proficiency in using complaint management systems and data analysis tools.
• Knowledge of relevant regulations and standards preferred (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR).
• Ability to work independently and collaboratively in a team environment.

COMPETENCIES

• Adaptability/Flexibility
• Ethical Conduct/Integrity
• Communication/Listening
• Detail-Oriented
• Interpersonal skills
• Personal Effectiveness
• Teamwork

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Familiar with complaint handling, CAPA, Non-conforming material processes, including root cause analysis techniques
• Ability to work independently and within a team environment
• Exercises judgement within broadly defined practices and policies
• Outstanding communication skills
• Ability to work with all levels of company staff
• Experience with electronic quality or document management systems (or other documentational software)
• Experience working in a highly regulated environment
• Exceptional skills in using basic computer software and hardware applications, including Microsoft Word and Excel

PREFERRED QUALIFICATIONS

• Bachelor’s Degree or equivalent in life science or engineering field
• 1-3 years’ experience in medical device quality assurance discipline
• Experience with FDA inspections and/or Notified Bodies Audits desirable
• Experience in ERP and eQMS systems
• Certified internal auditor

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities. This position may be required to lead/report on projects and ensure participants meet deadlines.

WORK ENVIRONMENT

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. This is a full-time position. Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m. This job may also operate in a cleanroom environment. Cleanroom environment requires personnel to wear company-provided cleanroom attire; e.g. scrubs, coat, bouffant, face mask, and gloves.

• Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required

PHYSICAL DEMANDS & WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand, walk, climb, sit, stoop, bend and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds and may be required to operate automated warehouse equipment; e.g. electric pallet jack, forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.

For more information or to apply, please email a resume to Origen Jobs.  Resumes may also be submitted by fax or mail.

Position Summary

The Quality Engineer I is responsible for technical duties within the Quality organization including validation and qualification,  calibration, and customer contact. These duties will support manufacturing operations, customer service, process improvement, and  regulatory requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential duties and responsibilities of this position include, but are not limited to the following:

• Plan and coordinate microbiological programs within the Quality department, including:
  • Bioburden monitoring per ISO 11737-1
  • Pyrogen monitoring per USP<161> and <85>
  • Cleanroom qualification ISO 14644
• Consult on microbiological aspects of sterilization qualification, including:
  • Gamma per ISO 11137
  • Ethylene Oxide per ISO 11135
• Perform routine complaint investigations and draft summary reports to customers.
• Develop Root Cause Analysis on problems originating from many sources, from production to end-user, including ownership of CAPAs and Nonconformance reports (NCR).
• Technical writing to include standard operating procedure (SOP) document, test protocols, and test reports, investigational summaries, risk assessment, and assistance with regulatory submissions.
• Support with process and design verification and validation activities.
• Execute risk assessment per ISO 14971 including risk planning, data collection, prediction of hazards and hazardous situations, and reporting.

Other duties and/or projects as assigned.

REQUIRED SKILLSETS

• Must be detail-oriented
• Must be proficient on a computer, possessing basic navigation and program knowledge
• Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
• Must be able to read, write, speak and fully understand English

COMPETENCIES

• Self-starter
• Good math, technical writing and computer skills
• Close attention to detail
• DOE and validation testing
• Familiar with quality tools and procedures
• Broad creativity and curiosity
• Organizational and time management skills
• Seasoned problem-solving skills
• Ethical Conduct
• Communication and interpersonal skills
• Can work with changing priorities
• Adaptability
• Results-driven
• Decision making

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• Bachelor’s degree in Engineering or 1 – 2 years’ experience in medical device quality / ISO 13485
• Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; hands-on troubleshooting ability
• Ability to understand and interpret customer needs; ability to work with all work functions (i.e. Regulatory, Operations, Human Resources, Engineering)
• Ability to work independently and lead or participate in a team environment

PREFERRED QUALIFICATIONS

• 3-5 years’ experience in medical device quality / ISO 13485
• 2+ years’ experience in a manufacturing environment Knowledge of Lean concepts

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities. This position may be required to lead/report on projects and ensure participants meet deadlines.

WORK ENVIRONMENT

This job operates in a climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The noise level in the work environment is generally moderate however periods of higher-level noise may occur.

This job may also operate in a cleanroom environment. The cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

• Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when required.

PHYSICAL DEMANDS & WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand, walk, climb, sit, stoop, bend, and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds and may be required to operate automated warehouse equipment; e.g. electric pallet jack, or forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.

Salary:

POSITION SUMMARY

OriGen Biomedical is a global leader in cryopreservation and cell culture. We collaborate with top researchers, clinicians, and business partners to enhance solutions, improve patient outcomes, and achieve customer satisfaction by providing safe and effective products that positively impact the quality of life. Reporting directly to the Director of Quality and Regulatory Affairs, the Regulatory Affairs Specialist will interface daily with Manufacturing, Operations, Research and Development, Customer Service, and Marketing in our corporate offices in Austin, TX.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential duties and responsibilities of this position include, but are not limited to the following:

• Evaluate regulatory risks and perform regulatory assessments of policies, processes, and procedures to new and existing or modified medical devices.
• Provide regulatory input to product lifecycle planning and anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Provide strategic input and technical guidance on regulatory requirements to development teams, including determining submission and approval requirements.
• Compile, prepare, review and submit regulatory submissions and renewals to authorities and assess the acceptability of quality, preclinical and clinical documentation for submission filing.
• Participate in project teams for purposes of identifying regulatory requirements.
• Plan for and coordinate meetings with regulatory authorities, responding to requests while developing and maintaining effective relationships.
• Collaborate with regulatory representatives of international distributors and/or affiliates to ensure continued compliance with international regulations.
• Reviews device labeling and marketing materials for compliance with global regulations.
• Maintain regulatory files to ensure the company’s compliance with regulatory requirements.
• Develop, review, and approve quality system documentation such as regulatory strategic plans, procedures, verification, and validation protocols and reports, and investigations (e.g., complaints, CAPAs, nonconformances, or deviations).
• Collaborate with Engineering, Quality Assurance, Operations, and Marketing to fulfill design control activities and other product development deliverables, including establishing regulatory project timelines.
• Ensure procedures and processes are maintained and updated to be consistent with regulatory requirements; Leads effective meetings, conducts presentations, keeps and maintains regulatory and quality records, and meeting minutes.
• Work closely with Quality to support audits/inspections.
• Utilize technical regulatory skills to propose strategies on complex issues and implement strategies that will ensure company compliance with regulatory requirements and timely marketing approvals or product registrations.

REQUIRED SKILLSETS

• Must be detail-oriented
• Must be proficient on a computer, possessing basic navigation and program knowledge
• Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
• Must be able to read, write, speak and fully understand English\

COMPETENCIES

• Manage and coordinate multiple large projects while guiding internal stakeholders on regulatory requirements.
• Effectively communicator both internally and externally.
• Knowledge of pertinent regulations in major jurisdictions (MDSAP and EU).
• Proven skills in preparing regulatory submissions in MDSAP regions and the EU. Experience with international regulatory submissions is a plus.
• Knowledge of FDA regulations and guidelines, including 21 CFR 820.
• Knowledge of ISO 13485, MDSAP, and EU MDR requirements.
• Self-starter managing day to day tasks and working in collaboration to accomplish deadlines and objectives.
• Interpersonal skills necessary for working effectively in a team environment.
• Works cross functionally to complete projects and testing.
• Exercises judgment within broadly defined practices and policies.
• Exceptional skills in using computer software and hardware applications, including Microsoft Word and Excel.
• Outstanding communication skills, both written and oral, in communicating across the organization and outside of the organization.

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)

• A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
• 4+ years experience in a regulated industry (e.g., medical products). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Experience interfacing with the FDA or international regulatory agencies.
• Experience in the medical device industry preparing regulatory submissions.

PREFERRED QUALIFICATIONS

• Completion of RAPS Regulatory Affairs Certification (RAC) program or Regulatory Compliance Certification (RCC) desired.
• Lean Six Sigma Certification is a plus.

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities. This position may be required to lead/report on projects and ensure participants meet deadlines.

WORK ENVIRONMENT

This job operates in a climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The noise level in the work environment is generally moderate however periods of higher-level noise may occur.

This job may also operate in a cleanroom environment. The cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

• Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when required

PHYSICAL DEMANDS & WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand, walk, climb, sit, stoop, bend, and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds and may be required to operate automated warehouse equipment; e.g. electric pallet jack, or forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.

Travel

5%

Salary:

Morning Shift: Work hours: five days, 8-hour shifts (Monday-Friday 5:30am – 2:00pm).

Evening Shift: Work hours: four days, 10-hour shifts (Monday-Thursday  2:15pm – 12:45am). 

The Clean Room Tech (CRT) is responsible for the assembly, testing, and packaging of medical devices and components. Required to understand and comply with drawings, written procedures, batch records, and must apply these standards to their work.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

• Ability to meet production schedules and deadlines according to quality standards
• Ability to work in a flexible and changing environment
• Ability to follow detailed written and verbal instructions
• Ability to learn multiple tasks and train in other areas as needed
• Ability to work with a variety of tools and equipment
• Ability to maintain all logs, paperwork, and forms accurately
• Required to understand, access, and make entries to documents on the company Electronic Document System
• Ability to accurately perform job duties with minimum supervision
• Ability to adhere to cleanroom dress code and policies
• Ability to work in a multi-cultural team environment and be a team player
• Ability to work in a cleanroom environment for extended periods of time
• Punctual and Reliable!!

Required Skill Sets

• Must be detailed oriented and be able to focus on a repetitive task for long periods of time
• Must be proficient on a computer, possessing basic navigation and program knowledge
• Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
• Must be able to read, write, speak and fully understand English

Competencies

• Adaptability/Flexibility
• Ethical Conduct/Integrity
• Communication/Listening
• Detail-Oriented
• Interpersonal skills
• Personal Effectiveness
• Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Basic computer navigation and program knowledge
• Strong organization and time management skills with the demonstrated ability to meet deadlines
• Pays very close attention to detail
• Ability to work independently and within a team environment  

Preferred Qualifications

• Prior Clean Room experience preferred

Compensation

Based on experience and ability

How to Apply

Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to origenjobs@origen.com. Unfortunately, due to the volume of candidates, it is not possible to follow up with all applicants, but we invite you to visit OriGen’s Career Page often, as we are updating with new opportunities frequently.  We look forward to hearing from you.

Morning Shift: Work hours: five days, 8-hour shifts (Monday-Friday 5:30am – 2:00pm).

Evening Shift: Work hours: four days, 10-hour shifts (Monday-Thursday  2:15pm – 12:45am). 

Position Summary

The Warehouse Packer is responsible for performing operations tasks within our fulfillment center in Austin, TX. Required to understand and comply with drawings, written procedures, batch records and apply these standards to their work. The individual will be required to participate in tasks associated with receiving, handling, storing, picking, and packing within the warehouse, ensuring quality standards are met. The individual will be required to perform inventory counts.

Essential Duties and Responsibilities

The essential duties and responsibilities of this position include, but are not limited to the following:

• Visually inspect products to specification including particulate matter and other product specific requirements
• Read and interpret product drawings
• Perform accurate counts of products to specification
• Assemble cartons, boxes and other packaging for final products
• Utilize pallet jacks, carts and dollies for movement of materials
• Assist with additional material requests from production teams
• Follow gowning requirements for obtaining and delivering materials from and to the production clean rooms
• Assist with all shipping and receiving related to the manufacturing activities.
• Ensure that all responsibilities within the scope of this job comply with the scope of the OriGen Quality System.
• Other duties and/or projects as assigned

Required Skill Sets

• Must be detailed oriented
• Must be proficient on computer, possessing basic navigation and program knowledge
• Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
• Must be able to read, write, speak and fully understand English

Competencies

• Punctual
• Reliable
• Adaptability/Flexibility
• Ethical Conduct/Integrity
• Communication/Listening
• Detail-Oriented
• Interpersonal skills
• Personal Effectiveness and a positive attitude
• Teamwork

Minimum Qualifications (Knowledge, Skills, and Abilities)

•  High school diploma or GED
• Experience in an ERP System (Epicor preferred),
• Experience with Microsoft Excel
• Able to review and analyze discrepancies
• Ability to work independently and within a team environment
• Excellent problem-solving skills, communication and leadership qualities
• Ability to work with all levels of company staff

Preferred Qualifications

•  Prior warehouse experience
• Proficient knowledge of warehouse procedures and policies
• Knowledge of warehousing Key Performance Indicators (KPIs)
• Knowledge of Lean concepts

Supervisory Responsibility

This position has no supervisory responsibilities. This position may be required to lead/report on projects and ensure participants meet deadlines.

Work Environment

This job operates in a climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The noise level in the work environment is generally moderate however periods of higher-level noise may occur.

This job may also operate in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

• Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required

 Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand, walk, climb, sit, stoop, bend and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds and may be required to operated automated warehouse equipment; e.g. electric pallet jack, forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.

Compensation

Based on experience and ability

How to Apply

Interested candidates should send their resume, title(s) of job for which they wish to be considered, and salary requirements to origenjobs@origen.com. Unfortunately, due to the volume of candidates, it is not possible to follow up with all applicants, but we invite you to visit OriGen’s Career Page often, as we are updating with new opportunities frequently.  We look forward to hearing from you.

If you are interested in working at OriGen, but do not see a current opening that fits your skillset, please use the form below and you’ll be notified if a similar role becomes available.

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