Title: QC Analyst
Duration: 6 Months (Possible Extensions)
Location: Morris Plains, NJ
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.