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Specialist, Quality Operations

0-1 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: Specialist, Quality Operations

Location: Kirkland, Quebec / Spokane, Washington

Company Overview:
Jubilant HollisterStier, a subsidiary of Jubilant Pharma Holdings Inc., is a rapidly growing integrated contract pharmaceutical manufacturer. We specialize in the production of sterile injectable formulations, as well as solid and semi-solid dosage forms, with facilities in North America and India. We are committed to providing innovative products and economically efficient solutions to our customers and stakeholders.

Job Overview:
The Specialist, Quality Operations is responsible for ensuring that production activities meet customer requirements, company policies, and regulatory standards. This position involves supporting production operations in detecting and resolving issues in real-time, participating in quality problem resolution, providing GMP and regulatory guidance, and performing ongoing monitoring of production operations.

Key Responsibilities:

  • Assist and support production operations to detect and resolve production issues in real-time.
  • Provide practical solutions and guidance for quality problem resolution.
  • Perform random checks during production operations to ensure compliance.
  • Conduct assessment rounds, monitor production activities, and provide summary reports on findings.
  • Perform and document ongoing process verification on packaging lines for each batch produced.
  • Serve as the primary quality contact for production issues, providing timely support and solutions.
  • Support the Investigation Team by submitting relevant information on production incidents.
  • Improve communication between departments to ensure smooth operations.
  • Perform SOP reviews, document complaint reports, and address other related tasks as assigned by management.
  • Lead improvement projects to enhance operational efficiency.
  • Other duties as assigned by the supervisor.

Qualifications and Requirements:

  • B.Sc. in Chemistry, Microbiology, or a related discipline. Candidates without a B.Sc. may be considered based on relevant training and experience.
  • Strong ability to assess the criticality of production incidents.
  • Excellent written and verbal communication skills.
  • In-depth knowledge of pharmaceutical processing techniques and cGMP regulations (Canada, US, and EU).
  • Proficiency in Microsoft Office and SAP.
  • Bilingual (French and English). Proficiency in English is essential.
  • Strong decision-making ability, especially in stressful situations.
  • Detail-oriented, methodical, and rigorous approach to work.
  • Strong interpersonal, organizational, and communication skills.

Compensation and Benefits:

  • Competitive base salary
  • Comprehensive medical, dental, and disability insurance programs
  • Group retirement savings program
  • Health and wellness programs

How to Apply:
If you're ready for a rewarding challenge and want to be part of a dynamic team, apply today!


Jubilant Pharma Holdings Inc. is committed to diversity and inclusion, creating a workforce that reflects the diversity of the patients and customers we serve. We offer an inclusive environment where employees can thrive and differences are embraced.

For more information, visit www.jublhs.com.