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Senior Associate, Quality Assurance Review

3-5 years
Not Disclosed
10 Jan. 27, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Associate, Quality Assurance Review
Location: Kirkland, Quebec or Spokane, Washington
Company: Jubilant HollisterStier, a subsidiary of Jubilant Pharma Holdings Inc.


Job Overview:

Jubilant HollisterStier, a fast-growing company within the pharmaceutical and biopharmaceutical sectors, is looking for a Senior Associate, Quality Assurance Review to join our team. This role will be responsible for ensuring that all pharmaceutical products manufactured and tested meet Jubilant’s and regulatory standards by auditing batch records and assessing compliance with Good Manufacturing Practices (GMP) and customer requirements.


What We Offer:

  • A culture that encourages professional growth and development.
  • Highly competitive base salary.
  • Comprehensive medical, dental, and disability insurance programs.
  • Group retirement savings program.
  • Health and wellness programs.
  • Work at a fast-growing, innovative company with global opportunities.

Key Responsibilities:

  • Audit and Review: Review batch documentation for finished drug products in a timely manner and release compliant batches into the SAP system.
  • Quality Management: Resolve and document issues related to batch audits and manufacturing quality issues. Perform necessary follow-ups when required.
  • Non-conformance Investigation: Review investigations of non-conformance and quality incidents. Reject non-compliant products and ensure adherence to GMP regulations and customer specifications.
  • Documentation Review: Review production-related documents such as Master Batch Records, Change Controls, SOPs, and Work Instructions to ensure compliance.
  • Record Maintenance: Maintain records in good order in compliance with Jubilant’s record retention schedule.
  • Product Quality Assessment: Serve as a resource to operations, evaluating the impact of non-compliance and quality incidents on product quality.
  • Additional Duties: Perform other duties as assigned by management.

Qualifications:

Education:

  • Required: BSc in Chemistry, Microbiology, or a closely related discipline.
  • Desired: Additional certifications in Quality Assurance or related fields.

Experience:

  • Required: 3-5 years of experience in Quality Assurance or Quality Control in the pharmaceutical or healthcare industries.
  • Preferred: Knowledge of pharmaceutical processing techniques, cGMP regulations for Canada, US, and Europe.

Skills:

  • Technical Skills: Proficiency in Microsoft Office, TrackWise, and SAP environments.
  • Languages: Bilingual in French and English, with proficiency in English essential.
  • Personal Skills: Strong attention to detail, thoroughness, and a methodical approach. Strong interpersonal, organizational, written, and verbal communication skills.

Work Environment:

  • Location: Kirkland, Quebec or Spokane, Washington.
  • Culture: Inclusive work environment where diverse perspectives are valued and embraced.

If you’re ready to take on this rewarding challenge and join a dynamic, growing company, we encourage you to apply today!

For more information, please visit our website at: www.jublhs.com.