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Senior Specialist, Quality Assurance 3rd Party image - Rise Careers
Job details

Senior 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.™

Basic Purpose: QA Sr. Specialist is responsible for obtaining technical documentation from suppliers. The Sr. Specialist will provide assistance with review and approval of documentation from 3rd party contract manufacturers (batch records, deviations, CAPAs, process validations, etc.) and assist the supervisor in monitoring and providing quality metrics to senior management.
Essential Functions and Responsibilities 
  • The Quality Assurance Sr. Specialist will administer customer complaints and annual product reviews in the Veeva system.
  • The QA Sr. 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 Sr. 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
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
  • 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.
 
Equipment and Applications
  • Microsoft applications and Veeva preferred.

 

Average salary estimate

$90000 / YEARLY (est.)
min
max
$80000K
$100000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

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EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
March 23, 2025

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