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. The hours are Monday-Friday 11:30 am-8:00 pm, with some holidays required. Training schedule (up to six months) is Monday-Friday 7:30 am-4:00 pm.

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 all required records and follow established guidelines for quality control, GMP, and safety.

Qualifications

• Required: Certificate in Biotechnology and/or a minimum of 1 - 2 years relevant experience.
• Preferred: 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: Experience in aseptic technique, GMP and clean room protocols.
• Required: Basic knowledge of lab techniques.
• Required: Ability to work in a cleanroom environment for extended periods of time.
• Required: Dexterity, coordination and some lifting.

Additional 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.