QC Analyst

Location: Morris Plains, New Jersey, United States
Salary: competitive
Job Type: Contract
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Title: QC Analyst

Duration: 6 Months (Possible Extensions)

Location: Morris Plains, NJ

Description:

The Quality Control Senior Analyst performs product release and stability testing using capillary electrophoresis methods (CE-SDS, icIEF) and UV spectrophotometry, reports test results, and performs activities to support equipment qualification and preventative maintenance. General laboratory maintenance as assigned by management.

ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES)

  • Executes biochemical and chemistry release and stability testing using CE-SDS and icIEF following SOPs and records data in a GMP compliant manner.
  • Supports release and stability testing using routine analytical techniques (e.g., concentration analysis by A280) as needed based on laboratory demand.
  • Participates in validation and technical transfer of analytical methods commensurate with experience.
  • Performs timely and accurate peer review of analytical test results reports.
  • Performs preventative maintenance and/or calibration activities or coordinates and schedules these activities with a third-party provider.
  • Responsible for cleanliness and orderliness of work area; maintains the laboratory in a state of inspection readiness; performs laboratory maintenance duties as assigned.
  • Participates in QC continuous improvement initiatives; looks for ways to improve compliance or efficiency and communicates to management.
  • Participates in laboratory investigations and root cause assessment and performs CAPA activities as assigned.
  • Maintains required training and training records and provides training to qualify other Laboratory Associates.

CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)

  • Excellent oral and written communication, organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
  • Ability to work in a team environment and perform job responsibilities with minimal supervision.
  • Knowledge with analytical methods currently used for purity, potency identity and impurities testing for release and stability of biopharmaceutical products.
  • Fluency in Windows and Microsoft Office.
  • Associate's Degree and a minimum of 5 years' experience in chemistry, biology, pharmaceutical science or a Bachelor's Degree and a minimum of 3 years of applicable GMP laboratory experience is required.

Sthree US is acting as an Employment Business in relation to this vacancy.

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