Please note this position requires extensive company paid training for a minimum of 3 months in our Maryland facility.
The Quality Control manager (QCM) reports to the Director of Quality Compliance.
The QCM will stay current on publications released by USP, FDA and other pertinent regulating bodies to ensure the Quality Control Analytical & Microbiology Laboratories and the Incoming Inspection departments are complaint in the areas of applications, release specifications, and documentation practices.
It will be necessary for the QCM to execute and understand all in-house test methods. This person will be required to perform release testing as well as manage the operations.
The QCM will ensure the analytical/microbiology laboratories and Incoming Inspection are in operation mode to support Production and the release of product. The QCM will ensure all Quality workforces are properly trained and the appropriate resources are provided to successfully fill the job requirements. The QCM will assess talent to assign tasks, functions, and projects to personnel with the appropriate capabilities and experience.
The QCM will make certain all raw materials are received, inspected, sampled, and disposition according to procedure. Incoming Inspection will work with suppliers and vendors to handle out of specification components at time of inspection.
This person will manage the flow of samples to results to ensure all valid data is reported timely to assist in the release of raw materials and finished products.
The QCM will facilitate the evaluation of new testing applications and instrumentation. The QCM will assist in the purchase and commission of analytical and microbiology instrumentation. The QCM will ensure there are efficient instruments for the work load of samples.
This person will ensure all methods transferred into a Quality Control function are validated and/or verified and all training has been documented. The QCM will work closely with the Analytical Chemistry department in designing experiments and technical documents.
The QCM will assist the laboratory personnel in resolving Out of Specification (OOS) results in the analytical and microbiology laboratories. S (he) will ensure the proper use of the instrumentation and validity of data. This person should be proficient in reviewing and interpretation of laboratory data. The QCM will design re-sampling and retesting procedures that are sound and will assist in finding root cause.
The QCM will assist in training new laboratory personnel. All training performed under the supervision of the QCM will be documented in accordance with established SOPs and the Nutramax training program.
The QCM will follow Current Good Manufacturing Practice (cGMP) documentation guidelines to record all procedures in a timely fashion. The QCM will maintain a safe working environment and will ensure that all equipment used in the testing procedures is calibrated and properly maintained.
Performance of other duties may be required for meeting company goals.
A Bachelor of Sciences (B.S.) or Bachelor of Arts (B.A.) or Masterís degree in Chemistry or a related science is required for the QCM position.
The QCM will have 7 to 10 years of laboratory experience in a cGMP facility, including experience with the proper operation of laboratory instrumentation, troubleshooting, and the generation and revision of SOPs and test methods. Effective interpersonal, self-motivation skills, and the ability to interact with all levels of personnel are required.
|Nutramax Laboratories, Inc.|
State or Province