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Basic Purpose:
The Senior Specialist, Quality Assurance is responsible for obtaining technical documentation from suppliers and administering the Supplier Audit database. The role will coordinate quality agreements, audits and risk assessments for API/Excipient manufacturers, contract laboratories, packaging suppliers and 3rd party contract manufacturers. This position will also provide assistance with review and approval of documentation from 3rd party contract manufacturers (batch records, deviations, CAPAs, process validations, etc.) and assist the Director in monitoring and providing quality metrics to senior management.

Essential Functions and Responsibilities
* Responsible for reviewing technical documents for 3rd party contract manufacturers. Technical documents include batch records, deviations/CAPAs, process validations, specifications, etc.
* Administers the Supplier Audit database and associated documents. Assists with performing supplier audits, risk assessments and maintaining audit schedules.
* Administers the CAPA system focusing on PA approval, closure and database tracking.
* Work with all levels of management to resolve issues discovered during review and participate in the problem-solving process.
* Partner with Supply Chain, R&D and Quality to obtain required supplier documentation to support qualification and risk assessment.
* Researches and prepares data needed for monthly quality metrics reporting to senior management.
* Other duties as assigned by management

Education/Training/Work Experience
* BS degree in analytical field of study.
* Five plus years relevant experience in a pharmaceutical/industrial experience

Specialized Knowledge and Skills
* Strong technical writing and documentation review skills.
* Strong interpersonal and team building skills.
* Familiarity with current regulatory trends and knowledge of current cGMP's
* Good organization, documentation and communication skills
* Attention to detail, strong technical skills.
* Strong working knowledge of PCs and Microsoft applications.
* Experience with Trackwise preferred

Equal Opportunity Employment

Providing "equal employment opportunity" is one of the most important people policies of Cosette Pharmaceuticals, Inc. Our goal is to do all that we realistically can to provide genuine equal employment opportunity to applicants and employees in all phases of our operation. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual's race, creed, religion, color, national origin, citizenship, ancestry, age, gender identity or expression, affectional or sexual orientation, marital status, domestic partnership, familial status, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, liability for service in the United States armed forces or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.