- 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)
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.
• 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