Production Associate I - Apligraf (Sunday-Thursday)
Organogenesis
Full-time
On-site
Canton, MA
Operations
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Role Summary
This is an entry level position in aseptic processing of a living product (Apligraf). The Associate will perform tasks under direct supervision to ensure safe and timely processing in Class 100 and Class 10K cleanrooms, supporting the Apligraf Manufacturing department.
Responsibilities
- Manufacture Apligraf according to established Master Batch Records and Operating Procedures.
- Prepare all media and sanitizing agents used in the Production areas.
- Adhere to all Operating Procedures, protocols, policies, regulatory requirements, GMP, and safety guidelines.
- Ensure batch records are complete and compliant with all protocols.
- Operate clean room equipment properly.
- Maintain required records and adhere to guidelines for quality control procedures, GMPs, and safety.
Qualifications
- Certificate in Biotechnology and/or 1–2 years of relevant experience
- Associates or Bachelor’s degree in biology or related science and/or 0–2 years of experience preferred
- Knowledge of Quality Systems regulations (cGMP) and clean room experience preferred but not required
- Experience in aseptic technique, GMP and clean room protocols desired
- Basic knowledge of lab techniques
- Ability to work in a cleanroom environment for extended periods
- Dexterity, coordination and some lifting required
Skills
- Cleanroom operations
- Aseptic technique
- Documentation and record-keeping
- Basic lab techniques
Education
- Certificate in Biotechnology or Associates/Bachelor’s in biology or related science
Physical Demands
- Medium work; occasionally lifting up to 40 lbs
- Standing up to 6.5 hours/day
- Pre-employment physical and lift test required