Senior Quality Assurance Specialist, PPQ/Commercial QA Projects

Nitto Denko Corp.•Milford, MA

19d

About The Position

The Senior QA Specialist is responsible for interfacing with and provide 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.

Requirements

BS/BA in science or equivalent work experience with 5+ years’ experience in either GMP Production or Quality Assurance.
Ability to provide expert advice and sound decision-making on all aspects of cGMP. He/she must have a 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.

Responsibilities

Provide leadership to any direct reports that manage client manufacturing programs at Avecia.
Act as QA project representative along with department management on Client Manufacturing campaigns and at client meetings (e.g., onsite and teleconferences) as directed by QA Project Team 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 department management.
Provide strong link/communication between the QA function/activities with all other departments at the Milford site.
Support the 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 and Quality Assurance procedures.
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.
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