QA Technician II - IPQA - Days

About the role

The Quality Assurance (QA) professional is responsible for providing real-time quality support to manufacturing operations and reviewing Batch Production Records (BPRs) to ensure compliance with current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), Work Instructions, and applicable regulatory requirements. This position works closely with Manufacturing, Packaging, Batch Release, Warehouse, and other Quality functions to ensure accurate documentation, appropriate product sampling and inspection, and timely resolution of quality-related issues.

Responsibilities

• Batch Production Record Review
  • Collect completed Batch Production Record (BPR) packets from Encapsulation and Post-Production manufacturing areas and log receipt of records.
  • Perform timely, detailed reviews of BPRs throughout the assigned shift to verify completeness, accuracy, and compliance with cGMP requirements, SOPs, and Work Instructions.
  • Collect and review Gelatin and Medicine area production packets on weekends, as required, to support timely record review and product disposition.
  • Identify documentation discrepancies, missing information, or other compliance concerns and work with appropriate personnel to resolve issues.
  • Process the issuance of labels, bags, cartons, ink, and other applicable packaging components in SAP as part of the batch record review process.
• Finished Product Sampling & Inspection
  • Perform Quality Assurance sampling and inspection of finished products in accordance with established procedures and Acceptance Quality Level (AQL) requirements.
  • Collect samples at designated stages of production, including the beginning, middle, and end of a production run.
  • Perform and document required inspections according to approved AQL checklists and applicable procedures.
  • Submit completed inspection and sampling documentation for review and record retention.
  • Perform non-routine sampling and testing of products and materials when required, including random sampling based on customer or business requirements.
  • Conduct pre-shipment quality checks at the request of Batch Release or QA Management.
• Retain Sample Management
  • Collect required retain samples for each production lot.
  • Ensure retain samples are properly identified, documented, and transferred to the designated warehouse Retain Cage.
  • Retrieve and submit finished-product retain samples when requested.
  • Prepare and palletize retain samples for transfer to off-site warehouse storage, as needed.
• Contract Packaging Quality Support
  • Perform sample evaluations of bottled products received from contract packaging organizations.
  • Document evaluation results and submit completed evaluations and associated BPR documentation to Batch Release for review.
• Label Control
  • Print product labels in accordance with approved procedures.
  • Verify label information for accuracy and compliance before release.
  • Maintain printed labels in a secure, controlled location.
  • Issue approved labels to Packaging/Production personnel before packaging activities begin.
  • Maintain appropriate accountability and documentation for label issuance.
• Quality Systems & Documentation
  • Initiate quality events in TrackWise and complete required supporting forms and documentation.
  • Issue controlled logbook numbers to Manufacturing.
  • Maintain completed logbooks in accordance with document-control requirements.
  • Retrieve archived or completed logbooks when requested.
  • Ensure quality documentation is complete, accurate, legible, traceable, and maintained according to applicable procedures and cGMP requirements.
• Manufacturing & Operations Support
  • Address product quality and documentation questions.
  • Support QA Hold activities.
  • Observe and verify manual weighing activities, as required.
  • Provide required QA approvals and sign-offs for packaging rooms and production activities.
  • Assist with authorized computer or system access issues in accordance with established procedures.
  • Partner with Operations personnel to resolve quality-related concerns while maintaining compliance and product quality.
• Perform other reasonable quality-related duties as assigned to support business and operational needs.

Qualifications

• Education & Experience
  • Required: High school diploma, GED, or equivalent with at least six months of relevant experience.
  • Preferred: Bachelor's degree with no prior related experience required.
  • An equivalent combination of education, training, and relevant experience is acceptable.
  • 1 year of experience in pharmaceutical, nutraceutical, dietary supplement, food, medical device, or other regulated manufacturing environments is required.