What are the responsibilities and job description for the Quality Assurance Specialist I position at Nitto Denko Avecia?
Purpose of the Position:
The position is responsible for documenting and auditing cGMP practices for the site. The position develops and revises QA procedures to strengthen cGMP compliance as per the USFDA Title 21 Code of Federal Regulation Part 210, 211 and Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Key Job Responsibilities:
Reviews quality records/batch records
Plays a key role in the cGMP compliance activities at the Milford site by preparing the site for FDA Pre-approval Inspections (PAI) and continuously works with other departments to maintain and monitor compliance with cGMPs.
Reviews and releases raw materials
Provide assistance during cGMP compliance inspections of the Milford facility. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections.
Assist senior staff in conducting internal CGMP audits and supplier audit as needed.
Strong attention to detail and self-checking skills
Job Knowledge Required:
The position requires BS/BA in science or with 1-3 years experience in either production or Quality Assurance. The position requires a strong knowledge of a cGMP regulation. Training and experience in quality systems, quality audits, documentation, change control, corrective preventative action and review of quality records is required.