Title: Research Associate
Job description:
The Research Associate is responsible for the processing, manufacturing, and evaluation of allograft tissues for tissue-based medical products and medical device development. This role performs allograft processing, laboratory testing, and quality assessments while ensuring compliance with established Standard Operating Procedures (SOPs), quality system requirements, and applicable regulatory standards. Key Responsibilities
- Process allograft tissues according to approved manufacturing procedures and Standard Operating Procedures (SOPs).
- Perform tissue recovery preparation, cleaning, trimming, shaping, decellularization, preservation, sterilization, packaging, and storage as applicable.
- Conduct laboratory analyses and quality assessments, including physical, biochemical, and microbiological testing of allograft tissues.
- Document manufacturing and laboratory activities accurately using batch records and laboratory documentation.
- Maintain traceability of human tissue throughout processing and manufacturing.
- Support process development, process improvement, and validation activities for tissue-based medical products.
- Operate, maintain, and calibrate laboratory and manufacturing equipment.
- Ensure compliance with Good Documentation Practices (GDP), GMP/GLP requirements, biosafety procedures, and applicable quality system regulations.
- Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, and R&D teams to support product development and continuous improvement.
- Maintain a clean and organized laboratory/manufacturing environment.
Preferred Qualifications:
- Associate's degree, College diploma, or Bachelor's degree in Biology, Biotechnology, Biomedical Science, Biomedical Engineering, Medical Laboratory Technology, Anatomy, Physiology, Biochemistry, Tissue Engineering, or a related life science discipline.
- 0–3 years of experience in a laboratory, tissue processing, tissue banking, biotechnology, or medical device manufacturing environment; entry-level candidates with relevant laboratory experience are encouraged to apply.
- Experience with allograft tissue processing, aseptic techniques, or cleanroom operations is preferred.
- Ability to accurately follow Standard Operating Procedures (SOPs), maintain detailed documentation, and comply with quality and regulatory requirements.
- Strong attention to detail, manual dexterity, organizational skills, and the ability to work effectively in both independent and team-based environments.
Job Type: Full-time
Pay: From $24.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
Experience:
- Clinical trials: 1 year (Preferred)
- Research: 1 year (Preferred)
Work Location: In person
