$80K — $100K *
The Quality Control (QC) Manager provides quality control oversight of internal and external testing activities, documentation and processes to assure compliance with company procedures and FDA regulations and assists with tasks necessary to achieve departmental and company goals.
• The QC Manager reports directly to the Senior Director of Quality Assurance or designee.
Duties and Responsibilities
• Oversight and review of routine and non-routine testing of GLP and GMP materials, including cell banks, viral banks, drug substance, drug products and process intermediates.
• As directed, manage laboratory staff to generate compliant data for characterization, release and stability of AGTC products.
• Manage Contract Testing Organization (CTO) performance to support timely and compliant collection of product test results.
• Collaborate with Analytical Development on the transfer of assays to CTOs along with qualification and validation activities in support of commercialization, process development and research and development.
• Collaborate with Analytical Development on assay optimization, as needed, to support current and future programs.
• Track product release testing, review results, prepare/approve COAs and COTs.
• Author and oversee the execution of product stability protocols and write reports to summarize the data generated to ensure regulatory compliance of stability programs.
• Perform assays and techniques requiring Subject Matter Expert (SME) skills, while serving as a first-line resource to other analysts in assessing and resolving technical issues.
• Participate in and support internal and external audit activities as directed, including those from regulatory authorities.
• Mentor and train analysts in theory and practice of assays.
• Assess and document analyst proficiencies and readiness to perform various types of analyses.
• Prioritize, schedule, and monitor multifaceted analytical projects, ensuring timely completion and efficient utilization of resources.
• Author, review, approve and maintain SOPs, forms, protocols and other controlled documents.
• Schedule material shipment and receipt.
• Investigate and document assay failures and OOS/OOT events.
• Identify and support relevant laboratory CAPAs.
• Execute Change Controls associated to laboratory or laboratory data.
• Other duties as assigned.
• This job description is subject to change at any time.
• B.S. degree in a scientific discipline
• At least five (5) years of QC experience (7 preferred) in a GLP/GMP environment, preferably at a biotechnology company.
• In-depth understanding of GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes and procedures
• In-depth understanding of USP and EP testing requirements for biologic products
• Demonstrated managerial experience in oversight of GMP testing activities, with late-stage and/or commercial experience preferred
• Great attention to detail
• Strong interpersonal skills
• Strong prioritization, organizational and negotiating skills
• Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management
• Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines
Valid through: 12/17/2020