Pharmaceutical Quality Assurance Specialist job in Philadelphia, USA

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Job type: Contract

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical seeking a Pharmaceutical Quality Assurance Specialist for a leading biotech company located in Philadelphia, PA.

Must be eligible to work in the US.

Job Responsibilities:

Perform Quality reviews, organize and file records that support operation activities for clean room suite manufacturing of a commercial ready raw material.
Support quality assurance processes, controls and batch history files for QA Operations and Lot Disposition
Support the efficient and timely reviews of batch records, testing, equipment, room qualification, training and other related records.
Support clean room readiness, environmental monitoring, gowning qualifications, line clearances, and room release.
Prepare release documentation for approvals.
Support GDP investigations as needed.
Support QA and Logistics activities for on-going projects
Assist with implementing GMP QA procedures
Other duties as assigned

Skills and Requirements:

BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 3-6 years of relevant experience
Detailed knowledge of Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals
Excellent oral and written communication skills
Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner.
Must be comfortable in a fast-paced environment and changing priorities.
Experience with use of an electronic QMS, MasterControl, Veeva preferred
Proficient with Microsoft Office Suite, Word, Excel, and PowerPoint

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at +(1) 215-531-6914 or s.briggs@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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INDCQA

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