Production Associate I - Apligraf (Sunday-Thursday)

Role Summary

This is an entry level position in the Apligraf Manufacturing department. The Associate will perform all activities involved in the aseptic processing of a living product (Apligraf) under direct supervision, supporting safe and timely processing in a Class 100 and Class 10K cleanroom. Hours are Sunday-Thursday 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 required records and adhere to guidelines for quality control procedures, GMPs, and safety.

Qualifications

• Required: Certificate in Biotechnology and/or a minimum of 1–2 years relevant experience.
• Preferred: Associate or Bachelor’s degree in biology or related science and/or 0–2 years experience.
• Preferred: Knowledge of Quality Systems regulations (cGMP) and clean room experience.
• Desired: 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; dexterity and coordination; some lifting.

Education

• Certificate in Biotechnology or Associates/Bachelor’s degree in biology or related science (required/preferred as indicated).

Additional Requirements

• Physical: Medium work, occasionally 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; dexterity and coordination.