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
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