Production Associate I - Apligraf (Sunday-Thursday)

Role Summary

Production Associate I - Apligraf (Sunday-Thursday). This entry level position involves aseptic processing of a living product (Apligraf) under direct supervision, supporting the Apligraf Manufacturing department to ensure safe and timely processing in Class 100 and Class 10K cleanrooms. Hours are Sunday-Thursday 7:30 am–4:00 pm, with some holidays required.

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‚Äì2 years of relevant experience.
• Associates or Bachelor‚Äôs degree in biology or related science and/or 0‚Äì2 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
• Recordkeeping and documentation
• Compliance with GMP and safety guidelines

Education

• Associates or Bachelor‚Äôs degree in biology or related science (preferred).
• Certificate in Biotechnology (preferred).

Physical Demands

• Medium work; occasionally lifting up to 40 lbs.
• Standing for up to 6.5 hours per day.
• Pre-employment physical and lift test required.