Production Associate I - Apligraf

Role Summary

Production Associate I - Apligraf. This is an entry level position responsible for aseptic processing of a living product (Apligraf) under supervision, supporting the Manufacturing department to ensure safe and timely processing in Class 100 and Class 10K cleanrooms. Monday–Friday, 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 follow established guidelines for quality control procedures, GMPs, and safety.

Qualifications

• Certificate in Biotechnology and/or a minimum of 1 - 2 years 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
• GMP compliance
• Basic laboratory techniques

Education

• Certificate in Biotechnology or Associate/Bachelor’s degree in biology or related science (preferred)

Additional Requirements

• Medium work with occasional lifting up to 40 lbs
• Standing up to 6.5 hours/day
• Pre-employment physical and lift test required