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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Associate I, Quality Control 3rd shift Wed - Sat
Norwood, MA 02062 US
Posted: 02/03/2023
2023-02-03
2023-05-01
Employment Type:
Contract
Job Category: Quality
Job Number: 3460
Job Description
Our client is 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.
Responsibilities:
Responsibilities:
- 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