Quality Control Manager

Our partner is looking for a Quality Control Manager in Rowley, MA. The role involves overseeing the QC Laboratory at the facility, which manufactures GMP Grade reagents for therapeutic products and/or in vitro diagnostics. The manager will be responsible for day-to-day operations, ensuring compliance with ISO and GMP requirements, and managing samples, test results, and documentation.

Responsibilities:

• Overall management of the GMP QC Lab Operation
• Manage a team of QC Technicians
• Oversee equipment maintenance and calibration
• Oversee third-party raw materials and product testing
• Oversee sampling and QC testing on incoming critical raw materials, as needed
• Perform in-process and final QC assays for enzymes or molecular biology reagents
• Investigate and document out-of-trend and out-of-specification test results
• Oversee and document lab deviations and investigations
• Disposition of nonconforming raw materials, intermediates, and final product
• Manage internal and external method qualification and/or transfers
• Support CAPA and other Quality Management System requirements
• Create and/or revise QC lab SOPs and STMs
• Provide training to QC Technicians
• Control QC laboratory documents and records, including test methods, specifications notebooks, and logbooks
• Validation of QC instruments and test methods
• Establish and implement the Environmental Monitoring and Clean Utilities Monitoring programs
• Manage reference materials, product retains, and stability samples
• Perform or oversee routine environmental monitoring and cleaning validation studies
• Assist in customer and/or regulatory audits

Requirements

• Bachelor's degree required in chemistry, biology, or related field; advanced degree preferred
• Minimum 7-10 years of relevant experience
• Minimum 2 years of direct supervisory experience
• In-depth understanding of cGMP-regulated quality control responsibilities and analytical methods, including qualification and transfer of methods
• Working knowledge of cGMP standards, regulatory compliance (US and other international agencies), and ISO 13485 Quality Management Systems
• Proficiency in enzyme activity assays, protein characterization and quantification, UPLC, qPCR, CE, PAGE, and agarose gel electrophoresis
• Experience performing microbial testing under USP <61>, <62>, and <85>
• Working knowledge of MS Office applications, including validation and control of Excel spreadsheets
• Experience in environmental monitoring
• Ability to perform statistical analysis and trending of data
• Familiarity with SAP, SharePoint, ELN, TrackWise, and laboratory information management system (LIMS) is a plus