QA Specialist, Analytical job in Philadelphia, USA

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Job type: Permanent

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 is urgently recruiting for a remote Quality Assurance Specialist of Analytics to join our client's Quality Assurance Operations team. The specialist will be responsible for support of GMP compliance with a focus on Manufacturing and Clinical Immunology areas. The candidate will provide critical review, organization, and Quality oversight of records generated during GMP manufacturing, release and stability testing of biotechnologically produced vaccines, as well as analytical records and data generated for studies conducted under GCLP and GLP guidelines/regulations.

Job Responsibilities:

Review of analytical records and data generated during the manufacturing and/or testing of vaccines for compliance to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), Good Clinical Laboratory Practices (GCLP) and Standard Operating Procedures (SOPs) and protocols. Records and data include, but are not limited to:
Conducts final review and approval of manufacturing-related documentation prior to batch release approval
Preparation of batch disposition documents for review and approval
Serves as a technical resource or subject matter expert on manufacturing and techniques within Quality Assurance
Review and approval of manufacturing technology transfer, qualification and validation documents internally and oversight activities to CDMOs
Provide Quality support and oversight for resolution of deviations and non-conformances related to manufacturing activities
Provide Quality review and approval for Process Descriptions, Master and executed batch records
Provide review and approval for generation of new or revised Quality SOPs and other controlled documentation. Author quality documents as assigned
Other duties as assigned

Skills and Requirements:

BS with 5+ years GxP industry experience
Excellent understanding of Quality Assurance systems
Strong communication and organizational skills
Excellent understanding of GMP, GLP, GCP and GCLP expectations
Knowledge of global regulatory expectations (including FDA and EMA)
The established recognition within QA as a technical expert
Demonstrated success in leading investigations and problem resolution
Demonstrated success leading a team and training junior staff
Demonstrated interest and ability to manage technical, operational, and administrative aspects of the team
Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations
The ability to represent the team cross-functionally; to apply an understanding of the team's place in the larger organization, and discuss changes, progress, and issues as they relate to other areas
The flexibility to strategize a new direction of his/her work when change is encountered or necessary; to help teammates with their own agility in a changing context
The accountability to have others' confidence in achieving deliverables that are complex, requiring interaction with other members of the immediate team and beyond
The ability to produce high-quality work on complex problems with cross-functional involvement; to anticipate and proactively prevent risks and compromises to quality
The capability to recognize inefficiencies in the team and identifies improvements constructively; to work across teams effectively and frequently collaborate on larger items involving other areas. To contribute significantly to cross-functional work; to network with senior internal and external peers in own area of expertise and demonstrates leadership and ownership of issues
The capability to consistently develop networks that are diverse in level and function, identify and initiate new relationships as well as creative alliances to accomplish business objectives, and inspire people with diverse needs to work together for mutual benefit

If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 929-388-1649.

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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