2 jobs found in Wellborn

Overview Summary : The Quality Assurance (QA) Analyst II, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally. External US Essential Functions: Review basic and technical documentation to include, but not limited to: Standard Operating Procedures Batch Production Records Commissioning, qualification and validation protocols and reports Deviation Reports Corrective Action/Preventive Action Plans Data Reports Drug Substance/Product Reports Review internal Quality policies, procedures and reports Assist in and perform inspection of final product containers and review and/or approval of executed process records and data Assist in and perform Quality audit functions to...

Overview Summary The Quality Control Cell Biology III will be responsible for assisting in the qualification of test methods for in-process and final products. Be able to work under minimal supervision. Perform advanced assays requiring precise analytical skills and understanding of cell biology and immunology principles. External US Essential Functions: Participate in training the QC Bioassay Staff at FDBT in the established release methods. Perform QC analytical testing for GMP release and stability testing as needed. Executes tech transfer, qualification and validation protocols as needed. Contributes to writing and revising Standard Operating Procedures (SOPs), Technical Reports, and other Good Manufacturing Practices (GMP) documentation as appropriate. Maintain data integrity and compliance with company SOPs and specifications, FDA, and cGMP regulations. Participate in functions involving teams which impact timelines, improve quality and increase efficiency. Complete all...