Title: Quality Control Laboratory Manager
Location: Exton, PA
Type: Contract to hire
Schedule: Monday – Friday 8AM-5PM

 Overview:
Growing Biopharmaceutical Company is looking for a hands on manager to lead and oversee their QC Lab in operational activities and process improvement. 

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

• Bachelor of Science Degree in Life Sciences or related field
• 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
• Ability to prioritize and successfully execute multiple tasks simultaneously
• Ability to work with a high degree of accuracy and detail