Production Technician

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.

KEY RESPONSIBILITIES:

• 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.

JOB REQUIREMENTS

• 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.