Quality Assurance on the Floor (QAOTF) Specialist III

Job Code:

Q1065

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JOB DESCRIPTION

The QA on the Floor (QAOTF) Specialist III is responsible for providing real-time Quality Assurance support for all areas that are directly or indirectly involved in the execution of GMP related activities at Matica, College Station Texas. The QAOTF Specialist III will make decisions regarding events that occur within the GMP environment and guide Manufacturing and Quality Control on the appropriate steps to address events. The QAOTF Specialist III will have a high-level understanding of Matica’s Quality Systems, current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), as well as professional skills of effective communication and listening. The QAOTF Specialist III will mentor and provide training for less experienced staff.  The QAOTF Specialist III will work irregular hours based on manufacturing needs. The QAOTF Specialist III must possess GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.; ICH Q7, 13485 and Part 11 compliance knowledge.

RESPONSIBILITIES

  • Provide Quality oversight to Deviations, Change Controls, CAPAs, New Product Introductions (NPIs), Quality Control Assays (QCAs), and Batch Records (BRs) to ensure that GMP products are manufactured, tested, stored, and distributed according to cGMPs and other applicable regulations. ​

  • Review of Batch Records on the manufacturing floor ensuring completeness, accuracy of routine work as well as footnotes/comments documented by Manufacturing staff. 

  • Apply knowledge of and adhere to cGMPs, company Quality Policies and site Standard Operating Procedures.

  • Advise departments on proper documentation requirements as needed.

  • Track and trend metrics for QA on the Floor audits, Logbook audits and In-Process Audits on-a-monthly basis for Senior Management.

  • Make sound decisions regarding compliance-related issues with moderate supervision.

  • Evaluate compliance issues and interact with regulatory inspectors and client auditors.

  • Perform other duties as assigned

QUALIFICATIONS

  • Bachelor’s degree in a life science.

  • 3-5 years of cGMP experience in QA or Manufacturing with an emphasis in Cell and Gene Therapy.

  • Gowning qualification is required for this position.