Production Associate I - Apligraf

Role Summary

Production Associate I for Apligraf — entry-level position supporting aseptic processing of a living product in Class 100 and Class 10K cleanrooms under supervision.

Responsibilities

• Manufacture Apligraf according to established Master Batch Records and Operating Procedures.
• Prepare all media and sanitizing agents used in 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 records and follow guidelines for quality control procedures, GMP, 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 operation
• Aseptic technique
• Documentation and record-keeping
• Adherence to GMP and safety guidelines

Education

• Not specified beyond qualifications above

Additional Requirements

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