Quality Control Lab Manager - Exton, United States - Beacon Hill Staffing Group

Description

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