QA Inspector Level I (1st shift)

Responsibilities

• Adherence to and enforcement of GMP compliance, including gowning attire, personnel hygiene, handling/storage of materials, and good documentation practices.
• Performing inspections of components, bulk product, work-in-process, and finished goods related to contract packaging.
• Reviewing documentation and verifying component attributes.

Essential Duties and Responsibilities

Responsible to 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.

Responsible for verification of documentation, room identification, equipment, and incoming components to a packaging room as follows:

• 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).
• 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.
• 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 Sharp 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 is preferred or a 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.