Quality Control Lab Coordinator - Night Shift in Maryland Heights, MO at Apex Life Sciences

Date Posted: 11/9/2018

Job Snapshot

Job Description


Apex Life Sciences is looking for a Quality  Control lab Coordinator – Night Shift

Scope of Position:

The Quality Control Coordinator coordinates activities, schedules, projects in a radiopharmaceutical quality control laboratory. Facilitates learning opportunities of laboratory technicians, and confirms that safety and laboratory practices are followed.  The Quality Control Coordinator further conducts quality control testing of raw materials, in process, finished product, and stability samples within the framework of site policies, departmental procedures, and current Good Manufacturing Practices (cGMP) regulations.  Participates in investigations, team projects, and special project studies to accomplish company and departmental objectives.  Records and reports data accurately and in compliance with current methods/Standard Operating Procedures (SOPs), United States Pharmacopeia (USP/NF), European Pharmacopeia and other compendia as applicable, and cGMP. Testing of instrumentation will include HPLC, GC, IC, ICP, AA, UV-VIS, Gamma Spectrometer, Dissolution, Dose Calibrators, Sodium Iodide Detectors, pH, balances, and TOC.

Schedule:

Saturday through Tuesday: 8:00 pm to 6:30 am

Essential Functions:

  • Performs set up, calibration, operation, and maintenance of laboratory test instruments/equipment.
  • Analyzes samples per established departmental/site/corporate policies, specifications, and procedures.
  • Prepares solutions and standardizes test solutions as defined in analytical method or compendia.
  •  Performs assigned work in a timely and safe manner conforming to regulatory, company, and compendial requirements.
  • May assist in routine verification of laboratory standards, solutions, and documentation.
  •  Practices cGMP, which includes, but is not limited to, proper laboratory documentation and maintenance, archival of documentation/raw data, attention to specification limits for any tests performed, and immediate notification of any out-of-specification (OOS) results.
  • Complies reports/documentation of analytical tests, ensuring reports are accurate and complete with documentation of procedures, equipment/instruments, and reagents used in analytical testing.
  • Demonstrates practical laboratory skills, and a thorough knowledge of chemistry theories, analytical techniques, and quality procedures.
  • Reviews and revises SOPs, analytical methods and related procedures/documents.
  • Follow environmental, health and safety (EHS) procedures and policies.
  • The colleague will need to be trained working with Radioactive material.

Requirements:

  • Associate Degree required in a scientific discipline; Bachelor Degree in Chemistry or related science field is highly preferred and some laboratory experience in a GMP regulated environment.
  •  Knowledge of compendia: USP, EP, and others as applicable, cGMP guidelines, FDA regulations; laboratory safety procedures, laboratory instrumentation, and SDS; knowledge of chemistry principals.
  • Language Ability:  Ability to read and understand applicable compendial methods (USP, EP, etc.), SOPs, general business periodicals, professional journals, technical procedures, and or governmental regulations; author scientific/technical reports, business correspondence and departmental procedures.
  • Math Ability:  Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals; perform simple statistical functions and graph data.
  • Reasoning Ability:  Ability to define problems, collect data, establish facts, and draw valid conclusions: interpret an extensive variety of technical instruction in mathematical or diagram forma and deal with several abstract and fixed variables.
  •  Computer Skills:  To perform this job successfully, an individual should have knowledge of Windows based software applications such as Word, Excel, and Outlook.  Knowledge of LIMs, and TrackWise.  Knowledge and experience with Chromeleon is advantageous.



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