JOB SCOPE:
•BA/BS in a relevant scientific discipline with a minimum of 5-8 years (or MS in a relevant scientific discipline with a minimum of 2-5 years) Quality Control experience in a cGMP organization
•Demonstrate ability to effectively and independently prioritize, manage, and complete multiple projects and tasks in a fast-paced environment
•Detailed knowledge of LIMS system (LIMS) and quality document system (Veeva)
•Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
•Experience with gowning, aseptic technique and general lab safety practices
•Strong and effective people management skills
Responsibilities
•Reporting to the Manager of QC Sample Management, the Quality Control Supervisor will be responsible for leading part of QC Sample Management team
•The individual in this role will supervise a growing team responsible for cGMP Sample coordination including cross functional collaboration with internal and external labs, as well as contribute to hands-on laboratory work
•Lead a team of associates responsible for sample management activities for QC Chemistry, Microbiology, Bioassay, Raw Materials from CMOs and various Development labs
•Oversee progress of daily schedule to ensure safe and timely completion of sample processing and quality records
•Author/revise SOPs, protocols, quality systems records such as deviations, CAPAs, change control
•Create weekly sample management schedules and run weekly team meetings
•Oversee the hiring, development, retention, and performance evaluation of QC Sample Management Associates, including routine 1:1s
•Participate in and partner with the Digital team to expand and optimize the use of LIMS (LabVantage) system
•Work with the Quality Control teams to continuously improve the quality, compliance, and efficiency of QC operations
•Provide support to audit teams for internal and external audits
•Controlled temperature unit (CTU) management, maintenance and troubleshooting
•Lead troubleshooting and provide guidance and support to the sample management team for compliance issues
•Train and oversee the teams training assignment and ensure compliance requirements remain current
•Establish and maintain a safe laboratory working environment
MA: QC SAMPLE MANAGER (232753)
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