Production Associate I - Apligraf (Sunday-Thursday)
Organogenesis
Full-time
On-site
Canton, MA
Operations
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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 extend 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 extend periods of time.
- Dexterity, coordination and some lifting required
Skills
- Cleanroom operations
- Aseptic technique
- GMP/compliance adherence
- Documentation and record-keeping
Education
- Biotechnology certificate or related science degree; or equivalent experience
Additional Requirements
- Pose any additional requirements if present in source