Quality Assurance Specialist (Cgmp)

TL;DR

Quality Assurance Specialist (Cgmp): Conducting and approving deviation and OOS investigations, while coordinating with customers and ensuring compliance with cGMPs. Focus on root cause analysis, CAPA identification, and maintaining metrics for laboratories to identify improvement opportunities.

Location: Rensselaer, NY

Salary: $128,700

Company

hirify.global is a company offering major medical, dental, vision, 401k and any statutory sick pay where required for temporary assignments lasting 13 weeks or longer.

What you will do

• Work with a cross-functional team to meet investigation deadlines, driving to root cause and identifying corrective and preventive actions.
• Ensure Quality Events are initiated and initial impact is completed and QA approved in a timely manner.
• Conduct, document, and approve deviation and OOS investigations, coordinating with customers as required.
• Apply 6M, 5 Why, or fishbone analysis to drive root cause.
• Maintain metrics for laboratories to identify CAPA opportunities, including analyst error rate, equipment failure rate, and test method issues.
• Provide investigation updates to cross-functional areas and management.

Requirements

• Bachelor’s degree in Chemistry or related scientific discipline with 6+ years of experience in a QC laboratory environment, or equivalent.
• Investigations experience including root cause analysis, writing, and CAPA identification.
• Experience working with customers as required by quality agreements and regulatory commitments.
• Experience working independently as the primary QA investigator and QA approver for Quality Events.
• Ensure all investigations are executed in full compliance with cGMPs, Curia SOPs, and global quality standards.

Culture & Benefits

• Equal Opportunity Employer / Disabled / Protected Veterans.
• Committed to working with and providing reasonable accommodations to individuals with disabilities.
• Offer major medical, dental, vision, 401k and any statutory sick pay where required for temporary assignments lasting 13 weeks or longer.