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A leading pharmaceutical company is seeking a Pharmaceutical Quality Control Laboratory Supervisor in Fairfield, NJ. The successful candidate will oversee lab operations, manage staff, and ensure adherence to quality control standards. This hands-on role requires expertise in analytical chemistry and prior laboratory management experience.
Fairfield, NJ
Garonit Pharmaceutical, Inc. Fairfield, NJ
1 week ago Be among the first 25 applicants
The Laboratory Supervisor is primarily responsible for the daily operation of the Quality Control Laboratory for a pharmaceutical manufacturer. This position will manage the staff to schedule all necessary testing to support manufacturing and release requirements as well as performing tests. This is a hands-on position.
Responsibilities
· Supervise, lead and coach a team of analysts to ensure compliance and support business objectives
· Method Development; validation protocols and reports
· Train and develop analysts
· Formulate, document, and maintain quality control standards and on-going quality control objectives
· Schedule workload to meet release objectives and deadlines
· Review, interpret, analyze and report HPLC data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines
· Author analytical methods and SOPs
· Clean, maintain, and troubleshoot HPLC instruments
· Develop specifications and analytical methods, as required
· Perform Laboratory Investigations (OOS) and root cause analysis, as needed. Identify CAPA
· Write Change Controls, as required.
· Manage Stability Programs
· Review lab notebooks and data
· Manage the outsourcing process of testing to contract laboratories
· Ensure lab safety and manage chemical inventory
· Improve the compliance of the laboratory operations as well improve the efficiency and reduce the cost of the operations
· Perform duties of QC Analysts, as required, including wet chemistry testing and HPLC testing, HPLC sample preparation and any other testing requirements
· Audit the work of QC Analysis
· Other duties assigned by Management
Qualifications
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