Production Associate I - Apligraf

Role Summary

This is an entry level position. The Associate will perform all activities involved in the aseptic processing of a living product (Apligraf), under the direct supervision of the Apligraf Team Leader/Apligraf Supervisor/Manager. The Apligraf Associate I will support the Apligraf Manufacturing department by performing the tasks that will assure the safe and timely processing of Apligraf, working in both a Class 100 and Class 10K cleanroom.

Responsibilities

• Responsible for manufacturing Apligraf according to established Master Batch Records and Operating Procedures.
• Responsible for the preparation of all media and sanitizing agents used in the Production areas.
• Responsible for adherence to all Operating Procedures, protocols, policies, regulatory requirements, GMP, and safety guidelines.
• Responsible for assuring batch records are complete and are compliant with all protocols.
• Responsible for proper operation of all clean room equipment.
• Responsible for maintaining all required records and adherence to established guidelines for quality control procedures, GMP’s, 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 of time
• Dexterity, coordination and some lifting required

Physical Requirements

• Medium work, occasionally lifting objects up to 40 lbs
• Standing up to 6.5 hours/day
• A pre-employment physical and lift test is required for this position
• Ability to work in a cleanroom environment, for extended periods of time
• Dexterity, coordination and some lifting required