QA Quality Systems - QC Support Specialist
Posted in Software 6 months ago.
Type: Full-Time
Location: Marietta, Pennsylvania
Position Title: QA Quality Systems - QC Support Specialist
Working Location: Pennsylvania
Employment Status: Full-Time Regular
Required Experience: 3 years
Required Education: Bachelor's Level Degree
Travel Required: 0%
Job Description:
GSK Biologicals, N.A. with our global quest to improve the quality of human life by enabling people to do more, feel better and live longer, is seeking a QA Quality Systems - QC Support Specialist for our vaccine manufacturing facility in Marietta, PA.
The QA Quality Systems - QC Support Specialist will perform the technical and compliance reviews of Quality Control (QC) Systems Procedures Development & Management (SOPs), laboratory validation activites, QC Methods, and oversee the Deviation, Change Control and CAPA management for the Marietta Quality Control department. Responsibilities include:
• Act as the QA liaison in conjunction with the QC department for performing investigation support, technical troubleshooting & problem solving on laboratory deviations to provide impact along with ensuring compliance, accuracy, and completeness. Facilitate Deviation Review Board meetings and discussions.
• Assist QC in level 1 (self inspection) audits and ensures audits are scheduled and conducted on time. Review audit reports looking for trends or repetitive issues.
• Assist and facilitate personnel activities such as SOP writing, product investigations with QC personnel to develop trend analysis and identify improvement opportunities. Develop and implement training programs for site quality systems and Quality Control.
• Maintain and follow-up with QC CAPA schedule and initiatives.
• Assist QC in preparing and maintaining QC metrics and generate reports for management review.
• Review calibrations performed on laboratory equipment for compliance to cGMPs and specifications/tolerances.
• Assist microbiology department with establishing alert/action levels for clean utility systems.
GSK Biologicals in Marietta is a beautiful community located along the Susquehanna River in Lancaster County, Pennsylvania. Our employees enjoy the proximity to larger metropolitan areas and benefit from more affordable housing, excellent school systems, and access to a multitude of recreational activities and the more relaxed lifestyle that the area has to offer.
Essential Skills:
If you believe you can be successful in a challenging vaccine manufacturing environment with a global organization and possess all of the following minimum qualifications, we encourage you to apply immediately:
• B.A. / B.S. in Biology, Microbiology, Chemistry, Biochemistry. Degree in other discipline if sufficient technical depth has been achieved by professional experience.
• 3-5 years pharmaceutical (consumer, pharma/biopharma, medical device, or vaccines) QA experience. Previous experience working in both Quality Control and Qualtiy Assurance operations is preferred.
• Demonstrated experience in quality systems to include deviation investigation, CAPA, change controls, and procedures development & management within QA or QC department.
• Fully versed in GMP’s, NIH and WHO Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance.
• Demonstrated ability to exhibit: flexible thinking; a willingness to develop oneself and others; the ability to build and maintain relationships; be customer focused; enable and drive change in a dynamic work environment; and exhibit a continuous improvement mindset.
• Computer skills in Microsoft Office applications and the ability to quickly and easily learn new applications.
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