Overview
Quality Assurance Specialist Jobs in Rensselaer, NY at Astrix
Title: Quality Assurance Specialist
Company: Astrix
Location: Rensselaer, NY
Pay Rate Low: 41 | Pay Rate High: 61
QA Investigation Specialist
Albany, NY | Onsite | PR: $1-61/hr | Monday–Friday, 8:00 AM – 5:00 PM
A leading CDMO in the Albany area is seeking an experienced QA Investigation Specialist to join their quality team onsite. This role will serve as a primary QA investigator and QA approver supporting deviation, OOS, and quality event investigations within a cGMP-regulated pharmaceutical manufacturing environment.
Responsibilities
- Partner cross-functionally to complete investigations within required timelines while driving to true root cause and identifying effective CAPAs
- Initiate and manage Quality Events in a timely manner, including initial impact assessments and QA approvals
- Conduct, document, review, and approve deviation investigations in accordance with cGMP requirements
- Lead and approve OOS investigations, including coordination with customers as required by quality agreements and regulatory commitments
- Utilize investigation tools such as 5 Why, 6M, and Fishbone analysis to determine root cause
- Ensure all investigations are executed in compliance with cGMPs, internal SOPs, and global quality standards
- Collaborate with QA management to ensure extensions are implemented prior to due dates when necessary
- Maintain laboratory investigation metrics including analyst error trends, equipment failures, and test method issues to identify CAPA opportunities
- Drive critical investigations to closure and provide updates to management and cross-functional teams as needed
- Support continuous improvement initiatives by identifying CAPAs and updating training modules to reduce analyst error rates
- Work independently while serving as a lead QA investigator and QA approver for Quality Events
Qualifications
- Prior experience within QA investigations in a cGMP-regulated pharmaceutical, biotech, or CDMO environment
- Strong knowledge of deviation investigations, OOS investigations, CAPAs, and root cause analysis methodologies
- Experience working cross-functionally within laboratory and manufacturing environments
- Excellent documentation, communication, and organizational skills
- Ability to manage multiple investigations and deadlines in a fast-paced regulated environment
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