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Quality Control Lab Manager - Pharmaceutical
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Job Location: Rehoboth Beach, Delaware - United States

Job #: 9834
Title: Quality Control Lab Manager - Pharmaceutical
Job Location: Rehoboth Beach, Delaware - United States
Employment Type:
Salary: $85,000.00 - $100,000.00 - US Dollars - Yearly
Other Compensation: 10% annual bonus
Employer Will Recruit From: Regional
Relocation Paid?: Yes


MY client is a 100 million Global Developer and Manufacturer of Pharmaceutical API`s (active pharmaceutical ingredients). Corporate HQ is Wilmington DE. They have manufacturering sites in MI, DE and France; and R&D in India and central distristibution in Australia. This is long time client; easy to work with!

The QC Lab Manager will be located in Rehoboth Beach DE; a very popular beach resort area ( 1 hour 45 minutes south of Philadelphia).

The site presents challenges for a QC professional with prior experience in a well-developed pharmaceutical QC laboratory setting. A number of systems and processes are in need of upgrade to enhance the overall quality and efficiency of the laboratory. This role requires someone with a strong desire to drive improvement, that can manage and develop a relatively young QC group and is able to collaboratively work with the operational personnel and effectively resolve conflicts..

The QC Manager has two direct reports; they are both QC supervisors: Position reports to the Site Quality Manager.

QC Supervisor #1: Supervise the scheduling and management of testing and review for the analytical work in the lab (raw material, in-process and finished product). Manages 5 chemists and 1 analytical chemist

QC Supervisor #2: Supervise the scheduling and management of Stability Testing, Microbiology, and instrument calibration/maintenance. Manages 2 microbiologists, 1 analytical chemist, 2 quality techs, 1 quality stability coordinator

The candidates ability to lead, develop and manage is as important as the technical skills.


Quality Control Lab Manager- Pharmaceuticals

Position Summary

Recognized Global Developer and Manufacturer of Pharmaceutical APIs is seeking a Quality Control Lab Manager.

In this role you will lead the Quality Control function at our Southern Delaware manufacturing site. The position reports directly to the Site Quality Manager

The primary objective of this position is to manage the Quality Control laboratory ensuring the integrity of all testing, methods and procedures to support manufacturing and release of products while ensuring that compliance with regulatory requirements and consistent with customer specifications.

Essential Duties and Responsibilities

  • Supervises all QC laboratory functions and serves as a technical lead in managing laboratory activities
  • Reviews and approves laboratory deviations and OOS Investigations
  • Reviews and trends laboratory data to support APRs and process improvements
  • Works with site management to set priorities within the laboratory based on production schedule, stability commitments, investigations and site projects
  • Ensure that programs for instrument calibration, maintenance and qualification are robust and to current standards
  • Develops QC staff and assures that all personnel are properly trained
  • Oversees Out of Specifications program ensuring compliance with current standards
  • Independently develops and recommends improvements to processes or procedures to drive efficiency through improved testing accuracy, turnaround time and compliance.

Position Requirements

  • Minimum B.S. in Chemistry or related science field
  • 5-10 years experience with increasing supervisory responsibility in a Pharmaceutical QC laboratory
  • Strong understanding of compendial methods and wet chemistry techniques
  • Experience in QC raw material laboratory and API setting preferred
  • Ability to delegate and inform management of priority issues
  • Working knowledge of LIMS, QMS, QRM, Label controls and Enterprise System
  • 2-4 years experience in method development and validation
  • Experience building teams and developing strong collaborative relationship among Skills
  • A natural problem solver with a sound working knowledge and application of formal root cause analysis tools

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