Quality Assurance Specialist

Kelly® Science & Clinical is seeking a Quality Assurance Specialist for a temp-to-hire position at a premier pharma company in Rosenberg, TX. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate:

$25-28/hour

Overview:

This client is a leading CDMO focused on providing services for the full drug product lifecycle. In this role, you will oversee inspections, sample collection, documentation, and material verification throughout all stages of pharmaceutical manufacturing and packaging, resolve quality issues collaboratively, and ensure compliance with GMP standards while communicating product release status and maintaining accurate records in a supportive team environment.

Schedule:

Monday-Friday, standard working hours

Responsibilities:

• Perform initial, in-process, and final inspections during manufacturing/packaging; resolve findings with Packaging or QA Management.
• Collect and label samples for release, validation, stability, and raw material testing; prepare and forward documentation to QC as needed.
• Monitor incoming materials in Quarantine; review receiving paperwork for accuracy and follow up on missing or incomplete CofAs.
• Inspect and approve/reject raw materials and components, including bottles, closures, cartons, and labels, verifying results with a second QA employee and updating system records accordingly.
• Prepare approval/rejection documentation, issue batch numbers, and assemble batch folders; coordinate with QA Manager on validation/stability designations.
• Issue batch documentation to production and review completed batch records for accuracy, resolving discrepancies with Production.
• Investigate material usage or yield discrepancies and assist in determining product disposition, including handling bright stock when applicable.
• Communicate product release status to Shipping and perform final pallet inspections to verify product name, lot, count, and order accuracy.
• Perform other related duties as required.

Qualifications:

• Bachelor’s degree Science or related field.
• 1+ years of experience in QA in pharmaceutical GMP environment.
• Strong working knowledge of GMP, SOPs, and DOPs.