QA Specialist II

This job specification is for a QA Specialist position.

This position requires expertise in the support of QA Supplier systems teams, required to work on quality issues and tasks associated with GMP Suppliers and Service providers and Systems where analysis requires an in-depth assessment, considering many variables and potential consequences. 

The candidate will need to have demonstrated proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on systems and training.

Job Responsibilities:

• Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements.

• Review and Approval of the Introduction of new Suppliers/Service providers and update in scope of approved Suppliers/Service providers.

• Completion and approval of Qualification review records in the Supplier management system within Gilead QMS to support approval of new supplier/service provider introduction/new material introduction.

• Approval of new supplier and material part numbers within Gilead’s product lifecycle management system

• Periodic Evaluation of approved Suppliers/Service provider

• Quality agreement Management

• External Deviation approval

• Ownership, assessment, and Approval of Supplier/Service provider Notifications including changes and quality issues.

• Support for regulatory and corporate audits when required.

• Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions.

• Review and approval of GMP Deviation investigations and CAPAs if required.

• Performs walkthroughs on behalf of the QA department to ensure site compliance to GMP

• Participates in authoring, reviewing, and approving Standard Operating Procedures (SOPs)/other types of controlled documents.

Knowledge and Skills:

• Prior experience in pharmaceutical industry is preferred and experience of making Quality decisions.

• Experience with working with external suppliers is preferred and ability to act when quality issues are seen.

• Relevant experience in a GMP environment related field of 3+ years and a BS in a science related education background.

• Approx 1+ years of relevant experience and a MS.

• Prior experience in pharmaceutical industry and working with GMP Suppliers .

• Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)

• Demonstrates working knowledge of quality assurance systems, methods, and procedures.

• Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.

• Demonstrates audit and investigation skills, and report writing skills.

• Good verbal, written, and interpersonal communication skills.

• Proficiency in Microsoft Office applications.

Typical Education and Experience: