Quality Assurance Specialist

Harba Solutions Inc.; Ashland (MA); On-site; USD 50,971 - 57,859; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

An established industry player is seeking a dedicated Quality Assurance professional to ensure compliance and quality in manufacturing processes. This role involves representing the QA department in client interactions, leading discussions on quality agreements, and supporting regulatory audits. With a focus on collaboration and adherence to Good Manufacturing Practices (cGMPs), this position offers an exciting opportunity to contribute to high-quality standards in a dynamic environment. If you are passionate about quality assurance and thrive in a regulated setting, this is the perfect chance to make a significant impact.

Qualifications

• 3-5 years of experience in Production or Quality Assurance in a regulated environment.
• Strong knowledge of current Good Manufacturing Practices (cGMPs).

Responsibilities

• Represent QA department in client meetings and manufacturing campaigns.
• Oversee implementation of client-specific CAPAs and ensure compliance.

Skills

Quality Assurance

Regulatory Compliance

Communication Skills

Problem-Solving

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 - $42.00/hr

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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.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance, Manufacturing, and Science

Industries

Biotechnology Research, Medical Equipment Manufacturing, and Chemical Raw Materials Manufacturing

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Benefits

• Medical insurance
• Vision insurance
• 401(k)