QA Specialist job in La Verne, 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 currently recruiting for a QA Specialist with a pharmaceutical company located in La Verne, CA.

Job Responsibilities:

Investigate and write investigation summary reports for deviations across all functions, including Manufacturing, QC, Validation, Engineering, Supply Chain, Maintenance, and Metrology.
Impartial investigator with the ability to conduct root cause analysis
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.
Normally receives general instruction on routine work, detailed instructions on new assignments.

Skills and Requirements:

BS/BA with minimum of 2 years of experience required.
Must have an understanding and application of QA principles, concepts, industry practices, and standards.
Applies knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) on a daily basis.
Prior experience within the pharmaceutical/biotech industry highly preferred.
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.

#LI-CN1

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