Quality Assurance Specialist III

Nitto Avecia; Milford (MA); On-site; USD 60,000 - 95,000; Full time

Job summary

An established industry player seeks a Quality Assurance Specialist III to oversee client manufacturing programs in early development stages. This dynamic role involves ensuring compliance with cGMP regulations, facilitating communication between departments, and leading discussions during client meetings. The ideal candidate will have a strong background in Quality Assurance and Production, with the ability to provide expert advice on regulatory compliance. Join a forward-thinking team dedicated to delivering high-quality pharmaceutical manufacturing solutions and making a significant impact on client projects.

Qualifications

• 3-5 years of experience in Production or Quality Assurance.
• Strong knowledge of cGMP regulations and technical issues.

Responsibilities

• Act as QA project team representative during client meetings.
• Ensure compliance with GMP regulations and client-specific quality agreements.
• Support customer complaint investigations until resolution.

Skills

cGMP regulations

Quality Assurance

Production experience

Expert decision-making

Education

BSc/BA in Science

Job description

Join to apply for the Quality Assurance Specialist III role at Nitto Avecia.

About This Opportunity

In this role, you will be responsible for interfacing with and providing quality input to client manufacturing programs that are in early stages of development or manufacturing customized medicines. The QA Specialist must ensure that the QA project team is well trained in phase-appropriate GMPs, global GMP API regulations, directives, and have familiarity with Avecia’s manufacturing campaign strategies for early phase products. This role also ensures that the QA Project Team is well prepared (e.g., summary documents or slides) to address client QA agenda topics that are submitted for response or discussion. From a Quality perspective, they shall oversee the progression of batches, including providing input to deviations, change controls, and CAPAs. Additionally, the role involves reviewing early phase quality agreements.

Key Responsibilities

1. Act as QA project team representative along with department management on client manufacturing campaigns and at client meetings (e.g., onsite and teleconferences) as directed by QA department management.
2. Prepare responses to customer-supplied QA agenda topics and lead discussions during client meetings, ensuring that outstanding questions are addressed with QA project team department management.
3. Provide a strong link/communication between the QA functions and activities with all other departments at the Milford site.
4. Support Customer QA SME and department management during Regulatory or Client audits.
5. Support review and negotiation of client-specific quality agreements with sponsors and liaise with QA Regulatory Compliance to ensure compliance with GMP regulations.
6. Ensure timely implementation of client-specific Corrective and Preventative Actions and provide updates to clients as needed.
7. Review quality records.
8. Support review of QA procedures to strengthen GMP compliance relevant to QA responsibilities.
9. Support review and approval of client deviations and generate/issue quality metric reports to management.
10. Assist in customer complaint investigations and follow up until resolution.

Required Skills/Abilities

• BSc/BA in science or equivalent with 3-5 years’ experience in Production or Quality Assurance.
• Ability to provide expert advice and sound decision-making on cGMP aspects.
• Strong knowledge of cGMP regulations and technical issues involved.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industry: Pharmaceutical Manufacturing