The Packaging Quality Auditor is responsible for the review of all packaging generated documents and records for completeness and correctness. The quality auditor serves as a verifier that the packaging process has been set up properly and that the line has operated according to current Good Manufacturing Practices and Good Documentation Practices.
ESSENTIAL DUTIES AND RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function in accordance with applicable law:
Adheres to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Reviews all packaging generated documents and records for completeness and accuracy in a timely manner.
Ensures retain samples are pulled and in the correct quantity for each production lot produced.
Responsible in the storage and identification of all retains and for closing out retain skids.
Collects Annual Review samples and paperwork and stores in the designated area.
Prints work order production recording sheets for each line.
Visually inspects and records retain samples, scans samples, and verifies that the UPC on the retain samples correlates to the UPC listed in the item master.
Verifies that the day lot code (DLC) is legible and accurate on the retain samples. Verifies that the item description in the POP matches the retain samples.
Verifies all scans are complete and that all SPC checks are entered into MES at the end of each shift.
Verifies all information on the packer labels including (but not limited to) SKU/FSC, date, and DLC are correct. Verifies that the item description in the POP matches the retain samples.
Verifies that the item description in the POP matches the retain samples.
Documents all batch changes accurately and clearly and collects retain samples with the new batch number.
Makes photo copies of all drug items and attaches them to the audit sheet.
Scans all paperwork to Quality Assurance for product release. Scanned POPs are uploaded to the shared drive immediately after review.
Communicates effectively to the area quality lead, quality engineer, and/or management of issues impacting product quality and addresses quality issues on a real time basis.
Works closely with the line leads and packaging supervisors/area leads to ensure line is properly set-up prior to running.
Identifies errors and rejects in a timely manner. Facilitates correction of the packaging records in a timely manner. Ensures that any documentation errors are promptly corrected according to GDP.
Close out POPs after each work order is complete, verifying that all required checklists and inspection checks have been performed and are complete. Ensures that all batches that were hooked up are returned and that the work order is released in MES.
Initiates the non-conformance incident (NCI) in MES with detail and clarity and escalates to the proper individuals for root cause investigation. Ensures defective inventory is placed on hold.
Provides guidance to the line operators and line leads in the acceptable tolerances for fill weights, label placement, torque, and defects.
Participates in quality initiatives to reduce non-conformities and improve the overall process.
Ability to cross train in SPC/QC inspection and work order closeouts and provides back-up coverage.
Other responsibilities as assigned.
Competitive salaries, comprehensive health/vision/dental insurance, company paid short term disability, company paid life and accidental death insurance, 401(k) plan match of 4.5% with immediate vesting, generous employee referral program, paid vacation annually, paid holidays annually, job advancement opportunities.
