Clinical Stability Associate - Contract - New Haven, CT
Proclinical is seeking a Stability Sample Management Specialist for a leading pharmaceutical company. This is a contract position is located in New Haven, CT.
Primary Responsibilities:
This role is responsible for all aspects of on-site stability sample storage and sample management. The successful candidate will be the point-of-contact between on-site testing labs and the stability group and will work closely with internal stakeholders to provide testing requirements and obtain completed analytical test results.
Skills & Requirements:
- Bachelor's degree with previous experience in an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline).
- Knowledge of GxPs and their application in the pharmaceutical environment.
- Ability to interact with cross-functional teams while representing the stability group.
- Proficiency with various MS Office programs, including Word, Excel, Outlook, and PowerPoint.
- Strong working knowledge of governing documents/regulations for pharmaceutical stability preferred.
- Knowledge of Lean Six Sigma, technical writing, SAS JMP or other statistical software, and Laboratory Information Systems (LIMS) are preferred.
The Clinical Stability Associate will:
- Conduct stability sample pulls at scheduled time points according to approved stability study plans.
- Deliver stability samples to labs and perform aliquots as needed, following Good Documentation Practices (GDPs) and Good Laboratory Practices (GLPs).
- Author stability Protocols, Reports, SOPs, and Quality documents as required.
- Track stability results generated internally and at external CMOs/ CLOs.
- Document stability results with strong attention to detail; able to recognize trends outside of expected results and communicate to management as required.
- Perform data entry/verification as required.
- Ensure training is current for all job functions performed. Attend all required Company training.
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) 215-531-6914 or s.briggs@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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