Stability Associate II, Analytical Development and Quality Control
Job in
New Haven, New Haven County, Connecticut, 06540, USA
Listed on 2026-01-16
Listing for:
Integrated Resources, Inc.
Full Time
position Listed on 2026-01-16
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
Job Title
Analytical Chemist
LocationNew Haven, CT
Duration12+ months (possible extension)
Pay Rate$37.93/Hour on W2
Responsibilities- Responsible for all aspects of on‑site stability sample storage and sample management
- 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)
- Perform data entry/review within paper‑based and electronic systems
- Point‑of‑contact between on‑site testing labs and stability group
- Author stability protocols, reports, SOPs and quality documents as required
- Work with internal stakeholders to provide testing requirements and obtain completed analytical test results
- Track stability results generated internally and at external CMOs/CLOs
- Document stability results with strong attention to detail; recognize trends outside of expected results and communicate to management as required
- Perform all job functions in compliance with cGMPs and maintain accurate and legible records
- Ensure training is current for all job functions performed
- Attend all required company training
- Bachelor’s degree with previous experience in Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline
- Knowledge of GxPs and their application in the pharmaceutical environment
- Able to organize work on a routine basis with minimal supervision and provide updates on tasks
- Ability to interact with cross‑functional teams while representing the stability group
- Able to navigate external vendor sites and portals for data extraction and review, as needed
- Proficient with Microsoft Office programs (Word, Excel, Outlook, PowerPoint)
- Excellent verbal and written communication skills
- Ability to understand and follow written procedures
- Office/lab environment experience with computer use, communications, problem solving, and collaboration during standard business hours
- Working knowledge of governing documents/regulations for pharmaceutical stability
- Previous technical writing experience
- Experience with SAS, JMP, or other statistical software
- Experience with Laboratory Information Systems (LIMS)
Position Requirements
10+ Years
work experience
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