QA Specialist job in San Dimas, USA

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP)

Location: United States

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

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in San Dimas, CA.

Job Responsibilities:

Performs a variety of activities to ensure compliance with applicable regulatory requirements.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Participates in reviews of Standard Operating Procedures (SOPs) to ensure instructions are clear and are consistent with quality objectives.
Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues for investigation support.
Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
May conduct or serve as lead/coordinator of investigations and corrective action (CAPA) recommendations related to manufactured products.
Works with operating entities to develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
Interfaces with contract manufacturers and suppliers to address documentation and compliance issues.

Skills and Requirements:

At least 3 years of QA experience, pharmaceutical or biotech industry experience, strong knowledge of cGMPs/GMPs/GLPs and experience with investigations, CAPAs, and/or root cause analysis.
Must have an understanding and application of QA principles, concepts, industry practices, and standards.
Strong verbal, technical writing, time management and interpersonal skills are required.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

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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