Specialist - Quality Assurance 3rd Party

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

Innovating every day.

• The QA Specialist will administer customer complaints and annual product reviews in the Veeva system.
• The QA Specialist will be responsible for reviewing technical documents for 3^rdparty contract manufacturers, up to and including batch records, batch record change controls, and specifications.
• The QA Specialist must work with all levels of management to resolve issues discovered during review and participate in the problem-solving process.
• Researches and prepares data needed for monthly quality metrics reporting to senior management.
• Other duties as assigned by management.

• Specialist level will be dependent on years of industry experience.
• Preferred BS degree in analytical field of study. AS degree may be considered in combination with industry experience.
• Preferred three(3) to five(5) years plus relevant experience in a pharmaceutical/industrial experience

• 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.

• Microsoft applications and Veeva 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.