What are the responsibilities and job description for the Quality Assurance Specialist III position at Nitto Avecia?
About This Opportunity
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. This 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 any batches including providing input to any deviations, change controls, and CAPAs. This role also must review early phase quality agreements.
Key Responsibilities
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. This 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 any batches including providing input to any deviations, change controls, and CAPAs. This role also must review early phase quality agreements.
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.
- The job requires a BS/BA in science or equivalent work experience with 3-5 years’ experience in either Production or Quality Assurance.
- The QA Specialist must be able 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.
