FierceBiotech and FiercePharma Jobs
Senior GMP Quality Assurance Specialist - Pharmaceutical Clinical Associates, LLC
Jul 30
Location: Malvern, PACategories: Pharmaceutical
Website: http://www.pharmca.com
Position Description
Our client, a biopharmaceutical firm is looking to hire a Senior GMP Quality Assurance Specialist.
Reporting to the Manager, Quality Assurance you will support our client’s quality process for work – 10-20% domestic and international travel maybe required.
Essential Functions Include:
• Ensure implementation and maintenance of quality systems, including but not limited to, SOP writing, SOP review and personnel training
• Responsible for independent cGMP batch record reviews and review of technical reports
• Review deviations, as well as implementing and tracking corrective and/or preventive actions.
• Perform internal and external auditing functions, writing audit reports and tracking the status of resulting corrective actions
• Create validation protocols and reviewing validation test documentation. Participate in managing validation processes performed by in-house or contract personnel
• Interact internally with R&D, clinical, regulatory affairs and senior management as well as outside contractors such as manufacturing and contract research
• Support quality efforts pertaining to the development, testing and production of several different therapeutic antibodies
• Provide orientation on quality processes to new employees and assist in training of newly hired QA personnel.
If you have the following, I want to speak with YOU!
Education: Bachelor of Science
Knowledge Requirements: cGMPs and SOP writing
Experience:
• Minimum 3 years experience in FDA or equivalent regulated industry biotechnology or pharmaceutical industry and at least 4 years performing Quality Assurance functions (for example; SOP and protocol writing, batch record review, investigations into deviations and out of specification results, training and auditing).
• Strong working knowledge of cGMP.
• Preferred knowledge and experience in GLP, GCP and ICH guidelines.
• Preferred experience in performing quality audits.
• Preferred experience in antibody production and characterization, process development, or assay validation.
