Quality Control Research Associate - III

Company: Rangam Consultants Inc.
Location: Santa Monica
Posted on: May 11, 2022

Job Description:

• Title: Quality Control Research Associate - III
• Under some guidance and supervision perform routine Raw Materials release testing by following established procedures as written.
• Participates as needed in the testing of raw materials by following analytical methods compendial methods and/or analytical procedures such as, pH, Osmolality, Conductivity, LAL, Identity, ELISA, Gel/Western Blot, FT-IR, HPLC, LC-MS, PCR, UV and Fluorescence spectroscopy, enzyme assays, microbiological assays and other applicable methods for the testing of Raw Materials and Reagents.
• Maintains instruments, by ensuring calibration and routine maintenance is performed in a timely manner.
• Leads laboratory OOS investigations, deviations, CAPAs and change controls, as assigned.
• Authors and revises Standard Operating Procedures.
• Compile data for trending or investigation purposes or conduct research in regulatory guidance and peer-reviewed journals.
• Performs GMP documentation with attention to detail.
• Gathering of documentation and data entry.
• Documentation and test record review.
• Keeps laboratory area clean and ensures waste is properly disposed.
• Keeps laboratory reagent and supply inventory.
• Supports the department with other duties as assigned. Basic Qualifications
  • Master's Degree and 2+ years' experience in biopharmaceutical or pharmaceutical industry OR Bachelor's Degree and 3+ years' experience in biopharmaceutical or pharmaceutical industry Preferred Qualifications
    • Strong understanding and experience operating within an GMP environment.
    • Working knowledge and understanding of analytical techniques to include HPLC, LC-MS, FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, Gel/ Western Blot, enzyme assays, microbiological assays, and other applicable methods to the testing of Raw Materials and Reagents within an GMP environment.
    • Preferred, experience leading OOS's, CAPAs, change controls, deviations and laboratory investigations.
    • Preferred, knowledge of current Good Manufacturing Practices (cGMPs), GxP, pharmacopoeia, and regulatory requirements for testing pertaining to the pharmaceutical industry.
    • Preferred, Knowledge of aseptic technique and previous experience with cell culture.
    • Exceptional attention to detail and ability to keep track of multiple ongoing projects
    • Experience writing, reviewing, or executing standard operating procedures, protocols, and reports.
    • Ability to perform duties with minimal supervision and be adaptable to a dynamic and fast-paced environment
    • Excellent interpersonal and organizational skills
    • Strong project and time management skills.
    • Excellent oral and written communication skills
    • Proficiency in MS Word, Excel, Power Point and other applications

Keywords: Rangam Consultants Inc., Santa Monica , Quality Control Research Associate - III, Other , Santa Monica, California