QA Specialist

  • Location: Houston, TX
  • Type: Direct Hire
  • Job #34487

Hiring Immediately: Pharmaceutical Manufacturer

Houston's North Side | Close to IAH Airport

Monday – Friday: 8am – 5pm | up to 85K Salary, DOE
(Candidate needs to have at least 1+ year working QA or QC in Cell Therapy Environments, and 3+ years of cGMP experience)

Position Overview
This position will be required to work collaboratively and cross-functionally with the Manufacturing, Facility, QC, QA, and Supply Chain to ensure optimum workflow and adherence to FDA/EMA compliance standards. This position will require technical knowledge of bioprocesses, attention to detail and organizational skills along with ability to operate independently, collaborate with cross-functional teams and manage competing priorities and timelines. This position reports to the Senior Manager of Quality Assurance.

Position Responsibilities
• Oversight of cellular therapy product quality from procurement through manufacture and distribution to clinical sites.
• Review and approve procedures, QC data, master batch records, and other QA controlled documentation, and associated change controls.
• Provide on-going support to manufacturing operations, review and approve product-related documentation, including batch records, quality control test results, and certificates of analysis, etc. and perform release of final product, as required.
• Support GMP material receipt, inspection and release.
• Ensure all product-related non-conformances and all associated CAPAs are initiated, investigated, and resolved.
• Ensure Change Controls are initiated, evaluated and implemented appropriately for all regulated changes.
• Act as the QA representative on the floor during manufacturing operations and audit operations as needed.
• Contribute to the maintenance and reporting of metrics related to batch record review and product disposition in support of the Management Review.
• Assist with implementation and maintenance GMP training system.
• Support inspection readiness plans and interact with regulatory agencies during inspections as needed.
• Assist with performing internal and/or external audits, as needed.
• Maintain the standards of ethical behavior and conduct to promote a quality culture with the organization and ensure the safety and reliability of company product.

Skills, Education and Experience Required
• Bachelor’s Degree in biological sciences, or related discipline
• Minimum of 3-5 years of Quality Assurance/cGMP Compliance experience in biologics, pharmaceutical, or similar regulated industry (1 year in cell therapy product Quality is highly desired).
• Working knowledge and ability to apply GMPs in conformance to U.S. standards (21 CFR 210/211 and 1271).
• Experience performing batch record review and compilation of batch packages
• Experience with Change Control practices/strategies
• Experience with Non-conformance and CAPA management.
• Knowledge of aseptic techniques and cleanroom behavior/practices.
• Ability to work both independently and be a part of a team, able to work with minimal direction and adjust workload based upon changing priorities. Must have exceptional attention to detail.
• Strong problem solving and analytical skills with demonstrated ability to independently manage a number of projects simultaneously and making sound decisions related to product quality issues.
• Good interpersonal, verbal and written communication skills in English
• Comfortable in a fast-paced small company environment.
• Comfortable working independently with minimal oversight.
• Proficient in Outlook, MS Word, Excel, Power Point and other applications


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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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