Position Summary:As a Research Associate II, your main task will be executing routine Quality Control (QC) testing activities as assigned. This position will support CAPA's, change controls, investigations, and deviations and participate in the development and validation of analytical methods for the Analytical Development group. You will also participate in testing, project support, data review, ordering of laboratory supplies, and general upkeep of the laboratory.
Principal Duties and Responsibilities:- Support QC analytical chemistry testing using laboratory equipment and instrumentation (HPLC, UPLC, GC, KF, Dissolution etc).
- Author technical reports as required.
- Ensure instrument calibration and qualification is up to date and performed on a scheduled basis.
- Troubleshoot any issues with instrumentation and coordinate repair with vendors as necessary.
- Coordinate with Supervisor on scheduling of testing for reagents and product samples.
- Participate in data review.
- Participate in method development and validation activities
- Coordinate external outsourcing of testing.
- Support CAPA, change controls, investigations, and deviations and the timely closure of these items with Quality Assurance.
- Follow Good Documentation Practices (GDP), maintaining contemporaneous records, filling out logbooks, forms, etc.
- Adherence to cGMPs at all times.
Requirements:- Bachelor's degree in Chemistry or related field
- 2+ years of work experience in a GMP Quality Control environment
- Prior experience with HPLC and UPLC
- Knowledge of CFR 210,211, USP and FDA/ICH guidance is preferred
- Knowledge of safe laboratory practices
- Strong verbal and written communication skills
- Experience with USP App IV dissolution apparatus is preferred
Working Conditions:
- Mix of office and laboratory environments.
- Must be able to work in chemical laboratory environments.
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Salary Range
$98,000-$110,000 USD
