Associate I, Quality Control (3rd shift Wed-Sat)
Norwood, MA 02062 US
Seeking a contractor for Quality Control Associate I position based at their Norwood, MA site. The individual in this role will perform cGMP QC testing for QC Chemistry. The position will be 3rd shift to cover Wed-Sat rotation and may require off-shift hours.
- Performs routine analytical chemistry testing including HPLC, UPLC, UV, Particle Analysis and Dynamic Light Scattering.
- Performs data entry and supports data review as assigned.
- Performs general laboratory support activities including reagent preparation, equipment maintenance, lab housekeeping etc.
- Write/revise SOPs, technical protocols and reports.
- Works with and within the LIMS system to record data and associated testing details.
- Perform HPLC (AEX) and NaOH plate reader-based assays in support of manufacturing process stat testing as needed.
- Supports sample management activities including sample retrieval/ receipt, sample logging, aliquoting and distribution.
- Orders, Manages and monitors stocking of QC lab supplies
- Complete and maintain cGMP documentation for work performed.
- Establish and maintain a safe laboratory working environment.
- Support testing for raw materials, intermediates, drug substance and drug product, including generation of testing data to support clinical studies.
- Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements.
- May assist with equipment qualification / validation activities, including maintenance.
- May troubleshoot issues related to equipment, laboratory procedures and assay performance.
- BS in a relevant scientific discipline
- At least 1 year of relevant experience in a cGMP organization with a focus on GMP testing
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Salary will be commensurate with experience
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