This is an entry-level position, Monday-Friday from 7:30 am-4:00 pm. The associate will perform all activities required under the direct supervision of the Manager. The associate will prepare all solutions (sterile and non-sterile) in an unclassified controlled area as well as a Class 10,000 clean room. Preparation requires measuring chemicals with exceptional accuracy, working in a cGMP environment, aseptically dispensing materials in a “hood”, and labeling the material appropriately.
Some holiday coverage may be required.
- Responsible for adherence to all Operating Procedures, Protocols, Policies, Regulatory Requirements, GMP, and Safety Guidelines.
- Responsible for preparing solutions according to Master Batch Records.
- Responsible for ensuring that Data Forms are complete and compliant with all protocols.
- Responsible for maintaining appropriate storage conditions for materials where appropriate.
- Responsible for proper operation of all clean room equipment.
- Responsible for maintaining all required records and adherence to established guidelines for Quality Control procedures, cGMP, and Safety Guidelines.
- Responsible for preparing solutions, aseptically dispensing, storing materials in appropriate conditions where applicable, labeling, transferring the material to Quarantine, and closing the room for GMP compliance.
- Responsible for assisting with document updates in Pilgrim electronic document system.
- Responsible for performing steps related to solutions in inventory database (Dynamics AX.)
- Responsible for maintaining current documents in the clean room.
- Responsible for maintaining monthly logs in the clean room.
- High school diploma required. Certificate in Biotechnology or related scientific field preferred.
- Ability to work in a clean room environment
- Problem solving skills
- Taking initiative
- Work as a member of a team
- Manual dexterity
- High degree of attention to detail
- Quality Systems regulations (cGMP) knowledge and clean room experience preferred but not required.
- Previous aseptic processing a plus.
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