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QA Quality Systems Specialist
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Pharmaceutical industry today.
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QA Quality Systems Specialist : MedImmune
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| Job Number |
57823 |
| Employee Type |
Full Time |
| Company Name |
MedImmune |
| Location |
Marietta
Pennsylvania
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
2/1/2010 |
| Industry |
Pharmaceutical |
| Job Type |
Quality-Assurance |
| Relocation |
Not Required |
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MedImmune
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| Description |
Basic Qualification
If you believe you can be successful in a challenging start-up manufacturing environment with a global organization and possess all of the following minimum qualifications, we encourage you to apply immediately:
• BA/BS degree required in a related technical field. 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.
• Demonstrated experience in quality systems to include deviation investigation, CAPA, change controls, and procedures development & management.
• Demonstrated experience in QA oversite of validation activites for phamraceutical indstry manufacturing, maintenance and QC operations.
• Demonstrated experience providing QA support of QC methods and laboratory investigations
• 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.
Details
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 Specialist for our vaccine manufacturing facility in Marietta, PA.
The QA Quality Systems Specialist will perform technical and compliance reviews of quality systems SOPs, site departmental SOPs, and lead the Deviation and CAPA management for the Marietta site. Responsibilities include:
• Ensure quality support and oversite for all Marietta site departments in Quality system activities (Deviations, CAPA, Change Controls, and Procedures Development & Management), validation activites, QC methods and laboratory investigations, and Techical Services Maintenance activities to include Calibration & Automation.
• Act as QA liaison in conjunction with the QA Operations group with manufacturing in completing product deviation documentation providing technical problem solving and investigation support to assure compliance to cGMPs. Facilitate Deviation Review Board meetings and discussions.
• Investigate, troubleshoot and provide input on product deviations to determine product disposition.
• Review and approve deviation investigations and CAPA reports.
• Maintain and follow-up with CAPA schedule and initiatives.
• Maintain and report quality metrics for the site quality systems.
• Assist and facilitate personnel activities such as development of batch records, SOP writing, product investigations with operations personnel to develop trend analysis and identify improvement opportunities.
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. |
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| Requirements |
Preferred Qualification
Additionally Preferred candidates will possess:
• Prior experience with SAP in an pharmaceutical manufacturing environment.
• Lean Six Sigma Training / Certification.
• Prior Quality Systems QA experience for vaccine manufacturing.
GSK Biologicals, N.A. is committed to being the Best Place for the Best People to do their Best Work. This is accomplished through our Total Reward competitive compensation package, our employee performance and development planning and our diverse, challenging, and innovative work environment. |
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| Contact Info |
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