Quality Assurance Technician

FARMAKEIO Pharmacy NetworkSouthlake, TX
Onsite

About The Position

The Quality Assurance Technician provides on-the-floor support for the cGMP production of implantable hormone pellets. This role acts as a Quality presence during receiving, manufacturing, and packaging by performing incoming inspections, line clearances, and in-process verifications. The technician documents observations, identifies discrepancies, and escalates concerns to ensure only compliant materials and processes are utilized.

Requirements

  • High school diploma or equivalent.
  • At least two years of experience in quality, inspection, manufacturing, or a regulated environment.
  • Ability to read and follow written procedures, specifications, and batch records.
  • Strong attention to detail with proficiency in Microsoft Office.
  • Ability to complete all required cGMP, data integrity, and safety training.

Nice To Haves

  • Associate degree or experience in pharmaceutical manufacturing or 503B facilities.

Responsibilities

  • Incoming Material and Component Inspection: Verify that active pharmaceutical ingredients, excipients, and packaging materials are received into appropriate status. Perform visual inspections for damage, cleanliness, and container-closure integrity. Compare items against purchase orders, packing slips, and specifications including lot numbers and expiration dates. Verify labeling, Certificates of Analysis, and Safety Data Sheets. Maintain material status labels and ensure inventory records reflect current disposition. Coordinate with Supply Chain, QC, and Warehouse for sampling, testing, or returns.
  • In-Process QA Oversight and Line Clearance: Perform and document line clearance before start-up, after changeovers, and at operation completion. Verify room and equipment readiness, including cleaning status and calibration records. Conduct independent checks on material identity, quantities, equipment settings, and yield data. Provide floor oversight during weighing, pellet compression, and packaging operations. Review documentation in real-time for compliance with Good Documentation Practices. Ensure proper identification and segregation of all product, components, and waste.
  • Quality Documentation and Support: Complete checklists, logs, and electronic records accurately and contemporaneously. Initiate or assist with quality event and nonconformance documentation. Maintain records in an audit-ready condition for regulatory or customer inspections. Communicate recurring errors or process signals to Quality management. Collaborate across departments while maintaining independent quality judgment.

Benefits

  • Comprehensive health, dental, and vision insurance plans with company-subsidized premiums.
  • 100% company-paid Short-Term Disability (STD), Long-Term Disability (LTD), and Life Insurance.
  • A 401(k) plan featuring a 4% company match to help you build for the future.
  • Generous Paid Time Off (PTO) so you can relax, recharge, and take care of what matters most.
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