QC Analytical Scientist
2 months ago
Our client is looking to fill the role of QC Analytical Scientist. This position will be fully remote.
Responsibilities:
- Coordinates quantitative and qualitative analytical testing of developmental, clinical, and commercial pharmaceutical and related products (including raw materials, in-process materials, and finished products) and reporting of results by contract laboratories.
- Reviews and trends analytical data, including raw data, of developmental, clinical, and commercial pharmaceutical and related products for accuracy and compliance with company and GxP requirements.
- Monitors stability studies of developmental, clinical, and commercial pharmaceutical and related products tested by contract laboratories.
- Reviews, enters, and maintains stability data for developmental, clinical, and commercial pharmaceutical and related products.
- Creates studies in LIMS and enters and reviews data in LIMS.
- Transfers analytical methods between Japan site, contract laboratories in the US, and other international affiliates.
- Prepares and maintains QC documentation, including protocols, reports, and test methods.
- Procures reference materials and monitors reference materials at contract analytical laboratories.
- Maintains and updates department documents required for regulatory compliance
- Assists in technical investigations
Required Qualifications:
- 5 + Years of experience of hands-on Analytical Laboratory testing specific to Pharmaceutical industry
- BA Degree in related science, ideally Chemistry
- Familiarity in GMP environment focused on analytical laboratory testing
- HPLC
- Dissolution analyses
- Karl Fischer
- USP General Chapters
- MS Office
- Electronic document management systems – First Doc, GQEDMS, CREDO, etc.
- Electronic quality management systems – TrackWise
- Laboratory Information Management System – LIMS
- Project Management experience
If you meet the required qualifications and are interested in this role, please apply today.
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
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