Quality Assurance Technician II-Quality Systems/Document Control

Cosette Pharmaceuticals • Lincolnton, NC

1d • Onsite

About The Position

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.™

Requirements

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

Nice To Haves

• 5 + years pharmaceutical experience in Document Control Environment

Responsibilities

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED