Quality Assurance Specialist-level TBD (388)

Equal Opportunity Employer

Level TBD

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.

Key Job Responsibilities:

Responsible for reviewing quality records/batch records

Act as lead auditor 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 Milford site Quality procedures.

Responsible for writing/revising Quality Assurance procedures to strengthen compliance with cGMPs.

Review and approve deviation and gather/issue quality metric reports to executive management.

Provide strong link/communication between the QA function/activities with all other departments at the Milford site.

Manage the Corrective and Preventative Action program. This may include chairing the Material Review Board and conducting QA investigations as per the internal procedures.

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.

Job Knowledge Required:

The job requires a BS/BA in science or equivalent work experience with 3-10 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. 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. The QA Specialist must have strong attention to detail and self-checking skills.