Production Associate I - Apligraf (Sunday-Thursday)

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

• Required: Certificate in Biotechnology and/or a minimum of 1 - 2 years relevant experience
• Required: 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
• Required: Dexterity, coordination and some lifting

Skills

• Aseptic technique and clean room protocols
• Lab techniques and basic biomedical knowledge
• Attention to detail and record-keeping
• Ability to operate clean room equipment
• Physical stamina for extended periods in a cleanroom environment

Education

• Certificate in Biotechnology
• Associates or Bachelor’s degree in biology or related science

Additional Requirements

• Physical requirements include medium work and occasional lifting up to 40 lbs; standing up to 6.5 hours per day
• A pre-employment physical and lift test are required