QC Analyst III

SGS_JOB_3894

Scientific
 New Hampshire
Microbial Control Testing
Deviations
CAPA
Change Control
Test Method
TrackWise
LIMS

Contract - 06 Months

Location (mandatory): Portsmouth NH The Quality Microbial Control Analyst V will be part of the Quality Microbial Control team, supporting the production of in-process and final product drug lots for customers. The role involves quality testing for customer stability studies, providing timely, high-quality results to meet Manufacturing demands. The Analyst will apply job skills, follow company policies, and contribute to projects and tasks of increasing scope. The role also provides technical support within the department and across the facility, potentially acting as a subject matter expert (SME) and supporting the supervisor in their absence.

Job Responsibilities:

  • Perform tests for In-Process, Lot Release, and Stability studies.
  • Support Utility and HVAC monitoring and sampling throughout the facility.
  • Review assay results and ensure they meet required standards.
  • Train team members and provide technical guidance.
  • Write Quality Records including Deviations, CAPA, Change Control, and Test Methods.
  • Manage projects, including method transfers, new instruments, and method qualifications.
  • Utilize Microsoft Suites (Word, Excel, PowerPoint) for documentation and reporting.
  • Work with Laboratory computer systems, potentially including GMP Quality Systems such as TrackWise, LIMS.
  • Identify and address deviations from accepted practices.
  • Apply Data Integrity principles in compliance with company guidelines.
  • Act as a back-up to the supervisor and make independent quality decisions with input.

Skills:

  • Perform tests for In-Process, Lot Release, and Stability studies.
  • Support Utility and HVAC monitoring and sampling throughout the facility.
  • Review assay results and ensure they meet required standards.
  • Train team members and provide technical guidance.
  • Write Quality Records including Deviations, CAPA, Change Control, and Test Methods.
  • Manage projects, including method transfers, new instruments, and method qualifications.
  • Utilize Microsoft Suites (Word, Excel, PowerPoint) for documentation and reporting.
  • Work with Laboratory computer systems, potentially including GMP Quality Systems such as TrackWise, LIMS.
  • Identify and address deviations from accepted practices.
  • Apply Data Integrity principles in compliance with company guidelines.
  • Act as a back-up to the supervisor and make independent quality decisions with input.

Education/Experience:

  • Education: Bachelor's Degree in Microbiology, Biochemistry, or related science fields.
  • Experience: 5-10 years of relevant experience in a microbial control or quality control setting, ideally within a GMP environment.

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