QA Specialist

Proclinical is currently recruiting for a QA Specialist with a global pharmaceutical company located in La Verne, CA. As the QA Specialist, you will work with operating entities to develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.

Job Responsibilities:

• Perform a variety of activities to ensure compliance with applicable regulatory requirements.
• Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Participate in reviews of Standard Operating Procedures (SOPs) to ensure instructions are clear and are consistent with quality objectives.
• Review manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues for investigation support.
• Work 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.
• Interface 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:

• Strong understanding of QA principles.
• Knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs),
• Previous pharma/biotech experience required.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at (+1) 215-531-5643 or c.nguyen@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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