Quality Control Supervisor Method Transfer

Harmans, MD

Posted: 09/01/2020 Industry: Manufacturing Technician Job Number: JN -092020-11918

Job Description

Quality Control Supervisor

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: Quality Control Supervisor
  • Location: Harmans, MD
  • Industry: Pharmaceutical
  • Hours: Mon-Fri 8AM - 5PM
  • Salary: $50.00hr (Paid Weekly - Benefits Available)
  • Employment Type: 6 month Contract
Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.

Job Scope:

This position is responsible for effectively hiring, developing, coaching, counseling, managing and motivating the QC method transfer and validation team. They are responsible for the timely and accurate completion of required analytical testing method transfer, verification, qualification and validation. They assure compliance to GMP and company specifications as well as relevant pharmacopeia compendia. The supervisor identifies areas for continuous improvement and/or implementation of industry best practices and drive implementation in the laboratory. The supervisor keeps laboratory management informed of all departmental activities and product related events.

Knowledge/Skills Requirements:
Supervises the daily activities of QC method transfer and validation team and assures that job activity deadlines are met on a timely basis
Generate, review and approve internal and external documents such as validation protocols, reports, STMs and SOPs
Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns
Direct supervision of laboratory staff including degreed chemists as well as additional laboratory support staff
Hires and oversees the training of QC department personnel. Assures that steps are taken to maintain positive personnel morale and development
Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated. Identifies possible source and corrective action needed and evaluates the impact upon the product
Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
Reviews work performed by department staff for accuracy, completeness and conformance to GDP and product specifications
Mentors and develops new department personnel including training in Standard Operating Procedures and On The Job Training (OJT)
Assures department is equipped with functional, calibrated equipment and necessary supplies
Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, and Laboratory Investigation Reports
Represents the QC Microbiology department in cross functional teams and internal/external meetings
Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured
Troubleshooting laboratory instrumentation issues
Providing back up assistance in performing laboratory testing as needed
Assumes other duties and responsibilities as assigned

Bachelor s degree in a chemistry or life science field
8 years experience working in a GMP Quality Control role with a minimum of 2 years of supervisory experience
Experience with cell-based assays, ELISA, DNA/RNA extraction, gel electrophoresis, qPCR, RT-PCR, SDS-PAGE, Western Blot, HPLC and Capillary Electrophoresis
Experience with Microsoft Office and Excel
Have the knowledge and ability to apply advanced scientific and regulatory principles to solve operational, as well as routine quality tasks.
Strong focus on responsiveness, ability to multi-task, attention to detail, consistent follow-up and ability to make timely and sound decisions (Quality and Business).

Must be able to prioritize. Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels Key leadership attributes:
o Delivers Results
o Fosters Collaboration and Teamwork
o Champions Change
o Engages and Inspires


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