QUALITY ASSURANCE MANAGER - PRODUCT RELEASE

Assures that Synthon Pharmaceuticals, Inc. and its affiliates and/or contractors associated with the manufacture, packaging, testing and distribution of drug substances and drug products comply with cGMP through auditing, records review, and data review.  Responsible for strategic oversight of the product release process and associated quality systems.  Monitors the distribution of drug substances and drug products manufactured and/or packaged for or by Synthon Pharmaceuticals, Inc. and maintains all related records. Oversees Quality Departure investigations at contractors and at Synthon Pharmaceuticals, Inc.’s testing and packaging operations at the RTP facility, and assures that follow ups to CAPA plans and training are met. Through conducting Annual Product Reviews, analyzes test data and recommends specification changes in compliance with current FDA regulations.

Essential duties and responsibilities:

• Reviews all manufacturing/packaging and testing records of goods manufactured/packaged for/by Synthon Pharmaceuticals, Inc.  Recommends disposition of intermediate stock and finished goods, and authorizes release on behalf of the Director, Quality Assurance, as applicable.
• Assists in the review and approval of Change Control requests and implementation at contractors and at the RTP site.
• Assists the Commercial Services Managers, in a QA capacity, in the launch of new products for the U.S. market.
• Reviews and approves master manufacturing and packaging batch records, as well as validation protocols and reports.
• Keeps current with cGMP and DEA regulations and guidances.

Requirements:

• Bachelor’s degree in a scientific discipline with a minimum of 5 technical and administrative years experience in a pharmaceutical QA/QC and pharmaceutical manufacturing/packaging environment.
• Must have excellent verbal and written communication skills.
• Must possess the ability to study complex issues, conceptualize and analyze various information
• Must be able to coordinate several projects at once, giving close attention to details, while demonstrating strong organizational skills.
• Must be able to work in a team environment.

Synthon Benefits:

Synthon Pharmaceuticals, Inc. offers a competitive salary and excellent benefit package, which includes 401k, medical insurance, life insurance and paid time off. 

Information and application:

For further information you can contact Jeanne Cuozzo, Director of HR at HR@synthon.com .
If you are interested in this challenging position, we look forward to your application. Please send resume with cover letter and salary requirements.