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Qc Lab Analyst Jobs

Company

SRG
Address Norwood, MA, United States
Employment type FULL_TIME
Salary
Category Staffing and Recruiting
Expires 2023-06-30
Posted at 11 months ago
Job Description
Job Overview


QC Lab Analyst


Contract length: 6-months


Location: Norwood. MA (100% onsite)



  • Establish and maintain a safe laboratory working environment.
  • Maintain compliance to data integrity and cGMP in QC lab in line FDA and ICH guidance.
  • Associate II (contractor) with cGMP quality control analytical testing experiences. The individual in this role will perform in process, release and stability testing in quality control Chemistry laboratory. Also, this individual may support special projects as assigned.
  • Involve in lab event (LE), OOS, OOT, OOE, and deviation investigations.
  • Review/write/revise SOPs, protocols, and reports.
  • May implement CAPAs and perform effectiveness check..
  • Document the testing procedure and results using Assay Performance Worksheets and/or LIMS as per GDP requirements and submit data packets for review.
  • Work on in-process, release, and stability testing for raw materials, drug substance, intermediates, and drug products in accordance with cGMP, SOP, FDA, ICH, and other regulatory requirements.
  • Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping and 5S activities, etc.
  • Follow current test methods and/or protocols to perform analytical testing.
  • Involve in supply management to ensure there are sufficient reference standard, reagents, supplies prior to your testing.
  • May assist with troubleshooting of assay methods and equipment.
  • Routinely use analytical equipment including, but not limited to HPLC, UPLC, LC-MS, GC, UV plate reader, particulate matter, particle size analysis with Dynamic Light Scattering, KF, Osmolality, etc.
  • Complete on job training activities.


Requirements


  • 3 years of general laboratory operations (Micropipette and analytical balance use, pH, reagent preparation, centrifuge, etc.).
  • Strong technical writing ability.
  • 3 years of hands on experience with HPLC and UV instrumentation and chromatographic software.


SRG ED&I and EEO Statement


  • ED&I: Impellam Group and its brands are equal opportunity employers committed to diversity and inclusion.
  • EEO Statement: Impellam Group is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.