PRIMARY DUTIES AND RESPONSIBILITIES:
- Performs equipment and room clearances based on cleanliness and adherence to SOP’s.
- Performs in-process inspections and physical testing of products to ensure compliance with specifications.
- Perform product release based on physical characteristics, compliance with in-process control limits and finished product specifications
- Performs and/or assists with batch record review for accuracy and completeness.
- Performs scheduled calibrations of manufacturing and physical testing equipment.
- Coordinate collection of finished goods samples for reserve/retain samples.
- Comply with cGMP regulations and follow all standard operating procedures.
- Assist in preparation for internal, customer and agency audits.
- Assist in ensuring all personnel comply with cGMP regulations and follow all standard operating procedures.
- Other related duties as required.
REQUIRED SKILLS, ABILITIES, AND QUALIFICATIONS:
- High school diploma or equivalent
- Experience in a manufacturing environment is desirable
- Ability to read and interpret technical procedures, SOP’s, GMP’s and governmental regulations.
- Strong communication skills, both written and verbal.
- Strong attention to detail.