This position will oversee daily operations at the MA Biocampus Quality Control Microbiology lab. This includes daily and stability testing of commercial product and EMCU testing at the Framingham campus. Main Responsibilities: Overseeing daily operations of the quality control laboratory to ensure adherence to the committed scheduled plans; Establish and prioritize lab quality control objectives; Maintaining laboratory compliance with GMPs and quality control processes defined according to internal and external quality requirements and regulations; Ensuring the usage of validated methods and executing any validation/transfer protocol as receiving unit; Contribute to develop and implement protocol (eg for validation, transfer, investigation); Managing and training laboratory staff, ensuring they follow best practices and safety guidelines; Elaborate training programs; Ensuring laboratory staff is qualified to perform testing by maintaining the lab qualification matrix; Conducting routine shopfloor of laboratory to identify improvement opportunities; Ensuring accurate and timely testing of received samples; Advise on testing schedules and priorities; Reviewing and approving laboratory test results and reports; Decide on the approval of test results; Maintaining laboratory equipment by applying maintenance, qualification and calibration plans; Advise about equipment maintenance schedules; Investigating and resolving any quality control events, issues or discrepancies; Implementing remediation actions from findings and CAPAs; Providing support during regulatory inspections and audits; Build remediation plans related to inspection readiness gaps, findings, deviations; Ensuring lab/facilities and instruments are kept in quality and safety status. Skills and Experience: 5 years of experience in quality control within the pharmaceutical industry, including knowledge of GMP and regulatory requirements; Ability to analyze complex data and laboratory results; Strong leadership abilities; Keen attention to detail; Proficiency in identifying issues and implementing effective solutions.
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