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Specialist - Quality Assurance 3rd Party

Cosette Pharmaceuticals Inc.
Lincolnton, NC Full Time
POSTED ON 3/27/2025
AVAILABLE BEFORE 5/27/2025

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: 
The Quality Assurance Specialist is responsible for obtaining technical documentation from suppliers. This role will provide assistance with review of documentation from 3rd party contract manufacturers (batch records, complaint reports, manufacturing/laboratory investigations, change controls, etc.) and assist the supervisor in monitoring and providing quality metrics to senior management.
 
Essential Functions and Responsibilities 
  • 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 3rd party 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.
Knowledge, Skills, Qualifications and Physical Requirements
 
Education/Training/Work Experience
  • 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 
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.
 
Equipment and Applications
  • Microsoft applications and Veeva preferred.

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