QA Senior Specialist - External Quality, Strategy, Processes and Metrics

QA Senior Specialist - External Quality, Strategy, Processes and Metrics

The responsibilities of the Senior QA Specialist is to maintain commercial product specifications current in all GMP systems, as well as the management of SAP workflow to ensure compliance to product dossiers and enable timely release of products. Lifecycle management of specification include revisions based on feedback from health authorities during post approval changes and submission of a commercial products to additional countries, or from continuous process verification where a change to approved specification is warranted.

The Senior QA Specialist needs to manage change control record in GVault pertaining to specification revision, and must be well verse in using the SAP system. Knowledge with specification setting and experience with assisting the response to health authority inquiries related to specifications are beneficial.

• 7+ years of relevant experience in a GMP environment related field and a BS or BA.
• 5+ years of relevant experience and a MS.

• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
• Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
• May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
• May assist or lead compliance audits as required. May interface with regulatory agencies as required.
• Interfaces with internal sites and contract manufacturers to address inquires from health authorities during product submission and post approval changes.
• Proficient in application of QA principles, concepts, industry practices, and standards.
• Demonstrates ability to effectively manage multiple projects/priorities.
• Has proven analytical and conceptual skills.
• Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
• Demonstrates excellent verbal communication, technical writing and interpersonal skills.
• Demonstrates working knowledge and good proficiency in Microsoft Office applications.
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
• Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
• Knowledge with IND/NDA/BLA submission process is desired.