Production Associate I - Apligraf

Role Summary

This entry-level position involves performing all activities involved in the 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.

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 of 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
• Record-keeping and documentation
• Quality systems and GMP compliance
• Equipment operation and maintenance

Education

• Relevant degree or certification as listed in Qualifications.

Additional Requirements

• Physical requirements include medium work with occasional lifting up to 40 lbs, standing up to 6.5 hours/day, and a pre-employment physical and lift test.
• Ability to work in a cleanroom environment for extended periods.