Job Description The QA Manager/Associate Director is mainly responsible for managing the day-to-day activities related to Bioanalytical GLP QA activities. Duties and Responsibilities Manage and ensure all the activities related to Bioanalytical GLP QA activities are completed as required Perform periodic audits of data packages Review and approve protocols and reports for GxP studies with an emphasis on GLP studies Ensure compliance with applicable regulatory guidelines Evaluate studies in determination of root cause and assess quality impact Recommend CAPA’s and follow-up to ensure CAPA’s implemented are effective. Perform training throughout the organization as needed Work with clients and senior management to develop QA project plans Participate in regulatory and partner inspections as necessary. Ensure timely follow-up to inspections findings Review non-conformance events, log books, procedures, and training as needed Write SOPs, reports, and conduct document reviews Implement process improvements with senior management Use scientific expertise to provide assistance to co-workers and troubleshooting, laboratory investigations, and problem resolution Qualifications: Minimum of 5 years of experience in the Bioanalytical GLP pharmaceutical/biopharmaceutical industry with a minimum of a B.S. Degree Previous technical experience in the areas of chemistry, biochemistry, or biology Must possess a working knowledge of GLP requirements and other policies/regulations as applicable Must possess a conceptual understanding of all Quality functions and business areas Must have the ability to function in a fast-paced environment and communicate effectively with senior management #J-18808-Ljbffr Primera Analytical Solutions
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