An exciting opportunity has arisen for a QA Specialist to join a global biopharmaceutical company based in San Dimas, CA. A very patient-focused company, who scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
- 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).
- Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.
- 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 support in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
- May assist lead/coordinator with investigations and corrective and preventive action (CAPA) relating to manufactured products.
- May work with Research and Development during new product start-ups, with guidance from senior colleagues.
- Normally receives general instruction on routine work, detailed instructions on new assignments.
- Position is Office only - No Medical Testing Required per Management
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Goldberg on +1 267 538 1182 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.