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 cGMP’s
· 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
