Quality Assurance Specialist III role overseeing cGMP documentation, record review, and audit readiness at Nitto Denko Corp.’s Cincinnati site. You’ll strengthen compliance by updating QA procedures, supporting inspections, and partnering across departments, with a standout focus on API manufacturing under ICH Q7 and FDA 21 CFR.
- Work to ICH Q7, FDA 21 CFR
- Hands-on audit and inspection support
- Cross-functional QA project involvement
The position is responsible for documenting and auditing cGMP practices for the site. The position develops and revises QA procedures to strengthen cGMP compliance.
Key Responsibilities
- Responsible for reviewing quality records/batch records
- Co-host during vendor/internal quality audits to ensure that cGMP compliance is at the required standard for API manufacture, in accordance with ICH Q7 Guidance and FDA 21 CFR requirements.
- Provide cGMP training to site staff as needed and assure that there is full understanding of the Cincinnati site Quality procedures.
- Responsible for writing/revising Quality Assurance procedures to strengthen compliance with cGMPs.
- Review and approve deviations, OOT and OOS.
- Provide strong link/communication between the QA function/activities with all other departments at the Cincinnati site.
- Act as QA representative on project teams. Reviewer of project documents (BRs, Technical Reports, Validation documents)
- Review Certificates of Analysis (COA) and Certificates of Conformance (CoC) for accuracy and release product.
- Provide assistance during cGMP compliance inspections of the Cincinnati facility. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections.
Required Skills/Abilities:
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 III must be able to provide expert advice and sound decision-making on all aspects of cGMP. The QA Specialist III 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. The QA Specialist III must have strong attention to detail and self-checking skills.