Production Operator I

Position Summary:

Pine Pharmaceuticals Operators shall be required to perform all necessary activities to provide the highest quality sterile drug products to our customers in a timely manner, while following all Pine Pharmaceuticals Standard Operating Procedures pertaining to sterile processing.

Essential Functions:

• Maintenance of his or her aseptic processing skills and shall demonstrate competency upon completion of the training program, and every three months thereafter, as described in SOP’s, including successful completion of assigned media fills associated with Production Operator I.
• The completion of aseptic garbing and gowning.
• The compounding of sterile products
• The cleaning and maintenance of aseptic compounding facilities.
• Equipment use and maintenance in sterile compounding areas.
• Use of environmental monitoring and equipment as outlined in SOP’s.
• Maintains all personal cGMP related training in a current state.
• Observes all environmental, health, and safety policies.
• Performs other duties and tasks assigned by management.
• Maintains proper documentation in appropriate logbooks and batch records.
• Qualified in or must become qualified in 1-2 processes outlined in the Operations Growth Chart.

Education and Experience:

• High School Diploma or equivalent.
• Cleanroom experience a plus.

Knowledge, Skills and Abilities:

• Familiar with cGMP and USP<797> requirements.
• At times, continuous repetitive motion of hands/wrist. Gripping, capping, filling syringes.
• Good interpersonal skills and willingness to work with others.
• Good organizational skills and attention to detail.
• Ability to prioritize tasks.

Posting for the following shifts: M-F 7a-3p and 10a-6p