Production Associate I - Apligraf (Sunday-Thursday)

Role Summary

This is an entry level Production Associate I position in the Apligraf manufacturing area. The Associate will perform aseptic processing of a living product (Apligraf) under supervision, supporting safe and timely processing in Class 100 and Class 10K cleanrooms.

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 quality control procedures, GMP, and safety guidelines.

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 experience preferred.
• Quality Systems regulations (cGMP) knowledge 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
• Quality systems and GMP compliance
• Lab techniques

Education

• Certificate in Biotechnology or related field; Associates or Bachelor’s degree in biology or related science preferred.

Additional Requirements

• Physical: Medium work; occasional lifting up to 40 lbs; standing up to 6.5 hours/day; pre-employment physical and lift test.