Quality Assurance Technician II-Quality Systems/Document Control

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.

Basic Purpose

Issuance of a range of cGMP documentation to support daily processes facility wide.

Essential Functions and Responsibilities

• Assign numbers per Good Documentation Practices in master logs for GMP document issuances.
• Issuance of Master Records, Notebooks, Logbooks, cGMP forms, etc.
• Ability to compile and enter data in support of Annual Product Quality Reviews (APQRs).
• Ability to review executed documents for adherence to good documentation practices and outlined procedures.
• Navigate and maintain documents in the electronic Quality Management System, Veeva Vault.
• Maintenance of the filing system for the retrieval and archiving of GMP documentation.
• Other duties as assigned by manager

Knowledge, Skills, Qualifications and Physical Requirements

The following describes the general knowledge, skills, qualifications and physical requirements normally associated with performing the essential functions of this job. In compliance with law Cosette Laboratories will consider varying or modifying these standards to provide individuals with disabilities an equal employment opportunity.

Education/Training/Work Experience

• High School Diploma
• 5 + years pharmaceutical experience in Document Control Environment (preferred), will consider comparable experience in related field

Specialized Knowledge and Skills

• Excellent communication skills (written and oral)
• Computer skills
• Good organizational skills
• Work well under pressure
• Strong knowledge of cGMP and FDA requirements
• Working knowledge of pharmaceutical processing, quality assurance/control processes and practices

Equipment and Applications

• Training System Software
• Enforcement Solutions
• Microsoft Office
• Microsoft Outlook

Work Environment and Physical Demands (List required PPE's)

• Ability to lift 25 lbs
• No PPE required unless entered manufacturing or lab areas

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.