Quality Assurance Specialist

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