QA Specialist II

Job Responsibilities

• Represent the QA department on client manufacturing campaigns and in client meetings (both onsite and remote) in coordination with QA leadership.
• Lead discussions and prepare formal responses to client QA agendas, ensuring thorough communication and follow-up on open items.
• Serve as a key liaison between the QA function and other site departments to promote cross-functional collaboration and alignment.
• Assist department leadership in supporting regulatory and client audits, including direct interaction with audit hosts.
• Contribute to the development, review, and negotiation of client-specific quality agreements, ensuring regulatory commitments are met.
• Oversee timely implementation of client-specific CAPAs (Corrective and Preventative Actions) and provide status updates as needed.
• Review quality records to ensure accuracy, completeness, and compliance.
• Assist in revising QA procedures that enhance adherence to cGMP guidelines related to project responsibilities.
• Support the review and approval process of client deviations and help compile quality metric reports for executive review.
• Participate in investigations of customer complaints and manage communications until resolution is achieved.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 3–5 years of relevant experience in Production or Quality Assurance within a regulated environment.
• Strong working knowledge of current Good Manufacturing Practices (cGMPs).
• Proven ability to provide sound QA guidance and make informed decisions based on technical and regulatory considerations.
• This position is fully on-site with the potential for one day of flexibility!
• Local or in-state applicants are strongly preferred due to the onsite nature of this role.