Overview
QA Specialist II Jobs in Medfield, MA at Harba Solutions Inc.
Title: QA Specialist II
Company: Harba Solutions Inc.
Location: Medfield, MA
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.
