Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in Rockville, MD.
- Ensure all cGMPs, validation, quality, safety and environmental regulations are met. Adhere to all safety guidelines and procedures
- Perform technical review of cGMP documentation and Batch Records for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures
- Provide advice and counsel on cGMP and related quality assurance issues to the value stream
- Demonstrate sound decision making relating to quality issues
- Provide on the floor QA support and perform QA Operations activities
- Take initiative to resolve quality documentation concerns
- Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes
- React to and escalate production issues
- Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary
- Write and/or revise controlled documents in support of job responsibilities
Skills and Requirements:
- BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience
- QA experience preferred. Minimum 1 year also preferred
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
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.