Quality Assurance Specialist

Quality Assurance Specialist

Quality Assurance

Rensselaer, New York, US

• Added - 28/05/2026

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

INDBH

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.