QA Inspector Level I (3rd Shift)

About the role

The quality inspection process directly impacts company compliance to regulatory requirements and customer satisfaction.

Responsibilities

• Ensure and enforce GMP compliance (including but not limited to gowning attire, personnel hygiene, handling/storage of materials and good documentation practices) throughout the production floor
• Verify documentation, room identification, equipment and incoming components to a packaging room:
  • Documentation: Ensure all batch record documentation is accurate (lot numbers, expiration dates, items number and related data are consistent throughout the record; AQL Report is accurate) and complete; read and understand process steps within the batch record to ensure compliance during the packaging procedure; review batch record for any additional requests, memos, deviations, change controls, etc.
  • Room/Equipment: Ensure room/equipment cleaning logs have been completed as applicable; room identification information matches batch record; all asset numbers are documented appropriately in the batch record; all equipment listed in the process is listed on the equipment verification pages and all applicable challenges are in the batch record; all calibrated equipment is labeled and within the appropriate calibration window
  • Incoming Components: Verify each component's attributes (at minimum – lot number, expiration date, description, item number and quantity) against Work Order, CoA/CoC, Component Receipt/Return Form and any other supporting documentation within the batch record; verify challenges were performed according to SOP and batch record requirements
• Pull and identify customers and retain samples as per batch record requirements
• Ensure batch records are being executed by all associates according to the process steps
• Review batch record for accuracy, legibility, traceability and accountability at the end of each shift or lot, whichever is first

Qualifications

• Associate or bachelor's degree preferred, or High School Degree with at least one to two years' related experience and/or training
• Experience in inspection of pharmaceutical or related industry is desired
• General knowledge of FDA regulations related to cGMPs is desired
• General knowledge of quality control/assurance is desired
• Good documentation and communication skills are required
• Good organizational and planning skills are required

Physical demands

• Regularly required to use hands to handle or write and to speak and hear
• Frequently required to stand, walk and reach with hands and arms
• Occasionally must lift and/or move up to 20 pounds
• May be subject to mandatory overtime if scheduling requires
• Specific vision abilities required include close vision, distance vision, and ability to adjust focus

Work environment

• Normally required to stand for long periods of time within a production room
• Working environment is clean and not normally subject to hazardous environment or conditions