Quality Assurance Specialist III, PPQ/Commercial QA Projects

Nitto Avecia; Milford (MA); On-site; USD 80,000 - 130,000; Full time

Job summary

A leading company in pharmaceutical manufacturing seeks a Quality Assurance Specialist III for their Milford location. In this pivotal role, you'll collaborate with clients on manufacturing programs, ensure compliance with cGMP regulations, and represent the QA function during key meetings. Candidates must possess a science degree and relevant QA experience, contributing to a dynamic team focused on excellence in pharmaceutical development.

Qualifications

• 3-5 years experience in GMP Production or Quality Assurance required.
• Expert advice on cGMP and Quality Systems highly preferred.
• Must keep updated with regulatory changes in cGMP.

Responsibilities

• Act as QA project team representative on client manufacturing campaigns.
• Prepare responses to customer QA agenda topics and lead discussions.
• Review quality records and support customer complaint investigations.

Skills

Attention to detail

Decision-making

Communication

Knowledge of cGMP

Education

BS/BA in science or equivalent work experience

Job description

Quality Assurance Specialist III, PPQ/Commercial QA Projects

Join to apply for the Quality Assurance Specialist III, PPQ/Commercial QA Projects role at Nitto Avecia

Quality Assurance Specialist III, PPQ/Commercial QA Projects

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About This Opportunity

In this role, you will be responsible for interfacing with and providing quality input to client’s manufacturing programs that are in late stages of development and/or commercialized. This includes interfacing with clients that are nearing process performance qualification (PPQ), PAI and commercial readiness, and that are approved to manufacture in global regions.

About This Opportunity

In this role, you will be responsible for interfacing with and providing quality input to client’s manufacturing programs that are in late stages of development and/or commercialized. This includes interfacing with clients that are nearing process performance qualification (PPQ), PAI and commercial readiness, and that are approved to manufacture in global regions.

Key Responsibilities

• 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.
• Prepare responses to customer supplied QA agenda topics and lead discussions during client meetings ensuring that any outstanding questions relative to the agenda topics are discussed with QA project team department management.
• Provide strong link/communication between the QA function/activities with all other departments at the Milford site.
• Support Customer QA SME along with department management in support of Avecia’s Audit hosts during Regulatory or Client audits.
• Support the review and negotiation of client specific quality agreements with sponsor and liaise with QA Regulatory Compliance to ensure that Avecia is in compliance with stated GMP regulatory commitments.
• Ensure client specific Corrective and Preventative Actions are implemented in a timely fashion and provide updates to clients, as needed.
• Responsible for reviewing quality records.
• Support the review of Quality Assurance procedures that strengthen compliance with cGMPs that pertain to QA project team responsibilities.
• Support the review and approval of client specific deviations and gathering/issuing quality metric reports to executive management.
• Support customer complaint investigations, as needed, and follow up with customers on all technical complaints until closure/resolution is reached.
• Support or perform disposition of advanced oligonucleotide products for pharmaceutical use, including pharmaceutical intermediates, active pharmaceutical ingredients (API) and adjuvants/constituent materials in accordance with approved specifications and procedures, including Avecia Enterprise Resource Planning System (SAP) transactions
  
  
  

Required Skills/Abilities

• BS/BA in science or equivalent work experience with 3-5 years’ experience in either GMP Production or Quality Assurance.
• Ability to provide expert advice and sound decision-making on all aspects of cGMP.
• Strong knowledge of the cGMP regulation and technical knowledge of the subject and the potential issues involved. This is achieved through a combination of experience in Quality Systems coupled with education and training in Quality Systems, cGMP, Quality audits, documentation, change control, corrective preventative action, validation, calibration, review of quality records, quality metrics, failure investigations and manufacturing and laboratory controls as per cGMPs.
• As the regulatory and cGMP requirements frequently change, the jobholder must also maintain current knowledge.
• Strong attention to detail and self-checking skills.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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