QA Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP)
  3. United States
La Verne, USA
Posting date: 09 Nov 2020

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in La Verne, 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 to enforce requirements and meet specifications.
  • May conduct or serve as lead/coordinator of investigations and corrective action (CAPA) recommendations related to manufactured products.
  • 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:

  • 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.
  • Experience with CAPAs, deviations, and/or investigations

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.