Job Description

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

• Bachelor's (Required)
• Laboratory Management: 2 years (Required)
• Analytical Chemistry: 3 years (Required)

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