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JOB DESCRIPTION:

JOB TITLE: Chemist II Quality Control

DEPARTMENT:Quality Control

SUPERVISOR:Team Leader Quality Control

Description:

The Quality Control Chemist will perform release testing at all stages of chemical manufacture including raw material, in-process and finished product as well as perform analytical method validation, cleaning verification and stability testing according to newly developed and established protocols as well as assisting Analytical R & D Chemists to develop analytical methods suitable for validation on an as-needed basis.

Responsibilities:

  • In a team setting and cGMP environment, under routine supervision, performs the physical and chemical testing of raw materials, materials in-process, and finished products to assess conformance to applicable standards.
  • Ensures the commercial laboratory testing process is well defined, adheres to current Good manufacturing Practices (cGMP), all equipment are appropriately qualified for analytical testing.
  • Prepares and standardizes test/volumetric solutions, standard solutions and samples for various chemical and physical test according to approved methods, perform and lead others in performing complex analyses including, but not limited to HPLC, GC, IC, UV-Visible Spectrophotometry, FTIR, and Karl Fischer
  • Responsibilities include peer review, evaluate and investigate results from various analyses and accountable for identifying trends and reoccurring issues. Additionally prepare, organize and final review paperwork and lab results for lot release to ensure accuracy and completeness, represent the team as a leader in problem solving, troubleshooting and documentation related to laboratory investigations.
  • Responsible for scientific leadership within the Analytical QC laboratory performing method verification, troubleshooting, and USP method verification. Suggest alternative methods, processes and procedures in solving problems and meeting changing laboratory opportunities. Review technical problems and procedures within the laboratory and recommend solutions to problems or changes in procedures.
  • Experience with Method Validation and Qualification activities, including protocol development, execute protocols and write summary reports.
  • Comply with Norac Pharma’s policies, procedures, quality standards as well as safety and environmental regulations. This individual will assure compliance with all US (e.g. FDA Guidelines, USP, cGMP) and compliance requirements.
  • Maintain working knowledge of assigned instrumentation, equipment, and operating procedures necessary to perform assigned tasks.
  • Prepare and execute stability protocol, initiate stability study and prepare interim and final reports detailing results of protocol execution.
  • Perform cleaning method validation and write cleaning validation reports.
  • Perform the following as needed:
    • Method transfer in-house and from clients
    • Method verification
    • Evaluate and validate client methods
    • In house methods validation, including contract and commercial products
    • Material and standard qualification
    • Routine lab instrument calibration
  • Perform day to day general lab activities e.g. sampling raw materials and in-process testing, cleaning lab glassware, monitoring stability chambers, maintaining cleanliness in the laboratory
  • Participate in analytical investigations and CAPA’s
  • Must be able to periodically lift and move bulky items of up to 50 pounds

Education / Experience / Personal Requirements:

  • Minimum 2-3 years in a Pharmaceutical Analytical Laboratory environment
  • Hands-on working experience of Laboratory Instrumentation (HPLC’s, GC’s, GC-Headspace, Ion Chromatography, FTIR, UV-Vis, KF, etc.)
  • Prior experience with characterization of raw materials, APIs and chemical impurities using FT-IR, UV-Vis, KF, ICP, NMR, LC-MS, GC-MS, Particle Size Analyzer and XRD is preferred
  • Knowledge and understanding of FDA, ICH, and USP requirements
  • Excellent interpersonal, communication and organizational skills
  • Excellent computer proficiency and technical writing skills
  • Degree in Science, preferably in Chemistry or related field

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Thank you for your interest in Norac Pharma however we regret that we are unable to acknowledge all submissions and only those candidates who we invite for interview will be considered to be confirmed applicants.