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Location: StratfordCT 06615 Document ID: A7061-0L0D Posted on: 2013-02-1102/11/2013 Job Type: Regular

Job Schedule:Full-time

Quality Control (QC) Manager

Quality Control (QC) Manager

Job Description

Supervises the development, implementation and maintenance of quality control systems and activities. Oversees development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy, efficacy and reliability of products. Prepares protocols, reports, CoAs and reviews and all documentation/review tasks in between. Coordinates interdepartmental activities. Develops budgets and monitor expenditures. Provides guidance to employees and supervises the work group.


  1. Conducts scheduled preventive maintenance and calibration of equipment (i.e., pH meter, HPLC, dissolution equipment, etc).
  2. Perform method development and validation as well as impurity analysis.
  3. Prepares standard and sample solutions as required by the test methods.
  4. Operates general analytical instruments during routine testing (i.e., HPLC, FTIR,).
  5. Performs wet Chemistry tests (i.e., pH, titration, etc.).
  6. Performs analysis on raw materials, intermediate and finished products.
  7. Maintains appropriate documentation (records and lab notebooks) as required by SOP’s.
  8. Complies with all current Good Manufacturing Practices (cGMP),safety requirements, laboratory Standard Operating Procedures (SOPs) and Company policies and procedures.
  9. Complies with good housekeeping and safety practices.
  10. Participates in troubleshooting of analytical test methods and laboratory instruments.
  11. Performs related duties as assigned.


  1. MS in Scientific Discipline (Chemistry preferred) or BA/BS with equivalent experience
  2. 3-5 years'experience with documentation and implementation of quality control systems
  3. Pharmaceutical Experience preferred
  4. Experience with method development and validation in a GMP environment.
  5. Knowledge of HPLC techniques
  6. Timely and Accurate Analysis
  7. Problem Solving Ability
  8. Strong initiative and self-direction.
  9. Strong computer, scientific, and organizational skills.
  10. Excellent communication (oral and written) and attention to detail.
  11. Scientific knowledge