Quality Assurance Specialist III, Phase 1/2 and Customized Medicines QA Projects

Nitto Denko Corp. • Milford, MA

85d • $76,700 - $95,700

About The Position

In this role, you will be responsible for interfacing with and provide quality input to client’s manufacturing programs that are in early stages of development or manufacture customized medicines. This includes interfacing with clients that are nearing or currently enrolled in Phase 1, 2 or 3 trials or manufacture customized medicines in any regulated region.

Requirements

• 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.
• 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.
• Maintain current knowledge of regulatory and cGMP requirements as they frequently change.
• Strong attention to detail and self-checking skills.

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.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees