Quality Assurance Specialist I

Harba Solutions Inc.; Hopkinton (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Specialist to enhance their QA department. This role involves representing the QA function in client meetings and ensuring compliance with Good Manufacturing Practices. You will lead discussions, manage audits, and oversee corrective actions, all while promoting cross-functional collaboration. The position offers a unique opportunity to contribute to high-quality standards in a regulated environment, making a significant impact on client satisfaction and operational excellence. Join a team that values your expertise and fosters growth in a supportive atmosphere.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• 3-5 years of relevant experience in Production or Quality Assurance.
• Strong knowledge of cGMPs and QA guidance.

Responsibilities

• Represent QA department in client meetings and manufacturing campaigns.
• Lead discussions and prepare responses to client QA agendas.
• Assist in supporting regulatory and client audits.

Skills

Good Manufacturing Practices (cGMP)

Quality Assurance

Regulatory Compliance

Client Communication

Education

Bachelor’s degree in a scientific discipline

Job description

This range is provided by Harba Solutions Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$37.00/hr - $45.00/hr

Direct message the job poster from Harba Solutions Inc.

• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Manufacturing, and Science

• Industries

  Biotechnology Research, Chemical Raw Materials Manufacturing, and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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