Pharmaceutical QC Team Lead (ID#012)

Largo, Florida

Post Date: 07/14/2017 Job ID: JN -052017-8796
Pharmaceutical QC Team Lead

Currently looking for a Team Lead to oversee the Analytical services, ultimately supporting QC (Product Development to Commercial Manufacturing) for a growing pharmaceutical company in the Tampa Bay, FL area.

Successful candidates with have direct oversight of the QC process as well as experience with analytical laboratory operations. Ensures lab abilities in HPLC, GC and AA and extensive cGMP experience.

MAJOR DUTIES AND RESPONSIBILITIES:
  • Prioritize and coordinate analytical and physical testing activities to meet timeline and budgetary commitments. Testing includes incoming raw materials, in-process samples, finished product samples and stability samples.
  • Full understanding of QC to encompasses raw materials, bulk and finished good and stability testing and planning
  • Ensure testing is performed accurately and in compliance with cGLP, cGMP, USP, EP, SOP and other approved test methods
  • Review data and reports ensuring precise and accurate testing is performed.
  • Manage the development, implementation and training of new validated quantitative methods for the laboratory.
  • Manage the stability program.
  • Train laboratory personnel in the use of equipment and analytical techniques.
  • Responsible for out of specification test results, investigation and implementation of corrective actions.
  • Solve complex analytical problems.
  • Lead project teams as assigned by the Vice President of Quality.
  • Assist Validation teams in cleaning validation activities.
  • Interpret Master Manufacturing Formula documents and support transfer of new products.
  • Ensure adherence to OSHA guidelines with regards to work practices and safety.
  • Qualification, calibration and maintenance of all laboratory equipment.
  • Write, review and revise SOP s and Test Methods as required.
  • Review and revise laboratory systems on an ongoing basis.
  • General laboratory maintenance.
  • Other duties, which may be assigned from time to time, by the Executive Management of the Company.
REQUIREMENTS:
  • Bachelor s degree in Chemistry
  • Must have a minimum of 8 years experience and previous supervisory experience in an analytical laboratory in an FDA regulated industry
  • Knowledge of Compendia (i.e. USP, EP, BP, JP, etc) testing.
  • Working knowledge of FDA regulation for drug/device especially for the analytical lab.
  • Knowledge of various analytical equipment and techniques utilized in an analytical laboratory including but not limited to pH, viscosity, specific gravity, infrared spectrum, HPLC, UPLC, GC, atomic absorption.
  • Demonstrated experience in Operational planning from the Lab to Manufacturing
  • Ability to work in a dynamic fast paced environment-sometimes rapidly shifting priorities. Ability to concentrate in such an environment and perform quality work.
  • Must be able to lift up to 15 pounds.
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