Quality Control Lab Manager
3 weeks ago
General Responsibilities:
Directs the Quality Control functions and provides direct support of all Quality Control processes, test procedures, and procedure validation activities. Measures, generates and evaluates data for the Certificates of Analysis to support the disposition of manufactured Bulk Drug Substance and Drug Product Injection lots. Works in conjunction with the Analytical Development team to optimize and transfers test procedures to the Quality Control department.
Responsibilities:
Manage a staff of Quality Control analysts and Environmental Monitoring specialists ensuring that day-to-day scheduling of activities is appropriately resourced
Maintenance of the viable and non-viable Environmental Monitoring Program, including monthly trend analysis, yearly alert and action level evaluation, equipment upkeep, logbook review, and order status
Manage laboratory equipment upkeep, calibration, and preventive maintenance and ensure proper documentation in logbooks and electronic management systems
Ensure all method validation is current. Test procedures include bioassay methods, binding assays, flow cytometry, gene expression analysis, and microbial control assays
Keep apprised of compendial changes and ensure compliance with compendia for all test procedures
Manage external vendors providing lab services and materials
Maintain appropriate inventory of materials through effective order management, coordination with Finance, and adherence to departmental budget
Ensure timely Quality Control testing is performed on incoming raw materials, intermediate Bulk Drug Substance, and final drug product
Participate in the establishment of phase-appropriate specifications
Ensure data integrity is maintained for all applications, programs, and executed work
Generation of protocols and technical reports
Author and manage QC change controls, test procedure revisions, SOP revisions, laboratory investigations, and root cause analyses
Raise critical quality issues to upper management
Perform internal audits to ensure compliance with cGMPs
Write and revise Quality Systems SOPs as necessary to maintain compliance
Training and development of employees
Ensure full compliance with applicable health and safety regulations (such as OSHA)
Willingness to engage with a high energy team in pursuit of organizational goals and strategies
Computer Skills:
To perform this job successfully, an individual should have knowledge of Database software; Project Management software; Spreadsheet software and Word Processing software.
Education:
Minimum Bachelor of Science degree in a scientific discipline
Experience:
Minimum 10 years of Quality Control experience in the biologics industry, with a minimum of 3 years management experience in Quality Control or Quality Assurance
Excellent knowledge of cGMP guidelines, USP/NF, 21 CFR Parts 210 and 211, 21 CFR Part 11, and other regulatory standards
Writing experience in a similar role in the biologics or pharmaceutical industry
Experience in aseptic processing and/or mammalian cell culture production
Flexibility and ability to adjust to changing priorities and unforeseen events using excellent time management skills
Ability to prioritize and successfully execute multiple tasks simultaneously
Ability to work with a high degree of accuracy and detail
Positive work attitude that supports teamwork and continuous improvement
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