Quality Assurance Disposition Specialist III

Job Code:

Q1066

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JOB DESCRIPTION

The QA Disposition Specialist III will disposition all materials manufactured at Matica College Station, Texas. The QA Disposition Specialist III will represent the QA department in internal and external meetings related to batch release to ensure quality requirements are met. QA Disposition Specialist III will serve as a technical leader in the implementation of Matica’s Quality Systems.  The QA Disposition Specialist III will be a mentor and trainer to less experienced staff members. The QA Disposition Specialist III will help identify compliance gaps during internal and external site audits. The QA Disposition Specialist III will support investigations into quality system issues as owner or approver. The QA Disposition 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 released documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).

  • Disposition of batches which includes maintaining a batch release tracking system, partnering with other functions to close all required deliverables to support the disposition of batches, which includes but not limited to executed batch records, deviations, change controls and Environmental Monitoring reports.

  • Review, revise, or draft Standard Operating Procedures (SOPs) in relation to the batch release process.

  • Track and trend metrics for QA on Deviations, CAPAs, and Change Controls on a monthly basis for Senior Management.

  • 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.