QC Analytical and Raw Materials Team Coordinator
Responsibilities:
• Responsible for supervising daily activities of laboratory group to ensure compliance with quality and reliability standards
• Supervises the use of chemical tests and various kinds of measuring instruments in accordance with approved methods and standard operating procedures (SOPs)
• Schedules and communicates with appropriate functional groups regarding status of activities and quality testing requirements
• Provides expert review of data, protocols and reports for adherence to cGMPs and good documentation practices
• Communicates aberrant results and leads investigation to determine root cause
• Ensures quality control training and reviews and approves standard operating procedures (SOPs)
Qualifications:
• Bachelor degree in a relevant scientific discipline (Chemistry, Biology, Biochemistry, etc.)
• Substantial quality control experience in the pharmaceutical/biotech/or other regulated industry
• Leadership/ team management skills
• Direct interaction with regulatory agencies
• Knowledge of current Good Manufacturing Practices (cGMP) principles
• Knowledge of FDA and EMA requirements
Please note this role is on shifts 5 days on and 3 days off
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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