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