Supervises the development implementation and maintenance of the quality control systems and activities. Oversees the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy, efficacy and reliability of company products. Develops budgets and monitors expenditures. Makes recommendation for corrective actions necessary to ensure conformity with quality standards. Ensures finished products conform to government and company standards and satisfy good manufacturing practices regulations and responsible for regulatory inspections and findings including follow-up. Coordinates interdepartmental activities. Supervises, selects, develops and evaluates personnel to ensure the efficient operation of the work group.
This is currenlty an interim position.
Supervision of QC personnel and/or performance of testing of in process, development, stability, raw materials and final product samples.
Coordination and oversight of activities and interdepartmental activities of the Quality Control Group
Performance of testing in accordance with standard operation procedures, if needed
Perform job function in accordance with the Agenus Quality Policy and Manual, as appropriate.
Coordinate and oversee the daily activities of the Quality Control and personnel.
Review and approve generated testing results.
Develop and support the execution of approved protocols for the validation of analytical instruments, test methods and reference standards.
Revise and development of standard operating procedure as needed.
Oversight of general laboratory activities, including but not limited to sample receipt, inventory control, reagent preparation, and equipment and instrument maintenance.
Laboratory and program auditing on a routine basis supplying recommendations as needed.
Direct and approve formal investigations, deviations, OOS and CAPA investigations and summary reports.
Review data from contract laboratories and collaborate with external partners.
Perform data trend analysis of environmental data, reference standard, test samples and controls.
Oversee the monitoring of temperature-controlled units using REES monitoring system.
Evaluate, train and select Quality Control personnel.
Specific skills relevant to the job:
Strong leadership and management skills
Prior knowledge of EP, USP or relevant guidance documents based departmental responsibilities (Analytical, Bioassay, Microbiology, etc.)
Strong understanding of cGMPs.
Requires B.S./M.S. in a scientific discipline or equivalent
Minimum 3-5 years relevant experience in a GMP environment
Equivalent is a minimum of 10 years plus relevant experience in a GMP environment.
Manager may require BS/MS or equivalent with 5-7 years relevant work experience.