Proclinical is currently recruiting for a QA Specialist with a biopharmaceutical company located in Lincoln, NE.
- Ensure all cGMPs, validation, quality, safety and environmental regulations are met. Adhere to all GSK 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.
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 contact Sarah Beshara at 267-477-3355 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.
Proclinical Staffing is an equal opportunity employer.