Quality Assurance Specialist II

About this opportunity:

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 acting as Project Lead for assigned client manufacturing projects, including reviewing quality records/batch records associated with the project or ensuring that all documents are reviewed and approved as required.
• Responsible for writing/revising Quality Assurance procedures to strengthen compliance with cGMPs.
• Review and approve deviation Provide strong link/communication between the QA function/activities with all other departments at the Cincinnati site.
• Perform quality assurance/compliance related tasks as assigned by the Department Manager. As assigned, 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.
• Ability 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. 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.
• Strong attention to detail and self-checking skills.