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Qa Validation Specialist/Senior Specialist

5+ years
$78,968 - $113,900
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: QA Validation Specialist/Senior Specialist
Location: Spokane, WA
Company: Jubilant HollisterStier LLC


About Jubilant HollisterStier:
Jubilant HollisterStier, a proud member of Jubilant Pharma, is a well-established company in Spokane, Washington. We provide comprehensive services that support the pharmaceutical and biopharmaceutical industries. Our Allergy business is a global leader in manufacturing allergenic extracts, focusing on treating allergies and asthma. Additionally, we are a recognized contract manufacturer of sterile injectable vials and lyophilized products.

At Jubilant HollisterStier, we are committed to growth, innovation, and providing the highest quality products and services to enhance value for our customers and stakeholders.


Position Overview:
We are seeking a QA Validation Specialist/Senior Specialist to provide technical expertise in the review and approval of critical documents, such as protocols, acceptance reports, SOPs, and specifications. In this role, you will serve as a quality representative for various departments, ensuring compliance with internal policies, industry standards, and regulatory requirements. This position will involve collaboration with production, engineering, IT, and technical services teams to validate processes, equipment, and systems.


Key Responsibilities:

  • Collaborate with production, engineering, maintenance, IT, and technical services to ensure all necessary documentation (e.g., process, cleaning, facilities, aseptic, and packaging) is developed to support activities.
  • Provide technical direction for new and ongoing validation projects to ensure compliance with internal policies, cGMPs, and regulatory requirements.
  • Review product transfer protocols and reports, assessing their impact on product quality and recommending appropriate actions.
  • Create and write SOPs related to QA Validation and documentation.
  • Review and approve validation protocols, acceptance reports, SOPs, and specifications.
  • Identify compliance issues and provide subject matter expert (SME) support for change control and system improvements.

Qualifications:

  • Education:

    • For Specialist: Bachelor’s degree in a scientific discipline or 5 years of relevant experience in lieu of a degree.
    • For Senior Specialist: Bachelor’s degree or 10 years of experience in lieu of a degree.
  • Experience:

    • Minimum of 5 years of related experience for Senior Specialist role.
    • At least 2 years of qualification/validation experience.
    • A minimum of 3 years of pharmaceutical industry experience in an FDA-regulated environment.
  • Skills:

    • Proficiency in Microsoft Word, Excel, and PowerPoint.
    • In-depth understanding of cGMP, European regulatory requirements, relevant USP chapters, and scientific principles related to sterile product manufacturing and testing.
    • Strong knowledge of quality principles and their relationship with manufacturing and testing.

Physical Requirements:

  • Ability to lift up to 20 lbs and sit for prolonged periods.

Compensation & Benefits:

  • Salary:

    • Hiring wage range: $78,968 - $113,900 annually, based on experience.
    • Opportunity for growth, promotion, and annual raises.
  • Benefits Package:

    • Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
    • Life Insurance, AD&D, Short and Long-Term Disability
    • 401(k) with company match
    • Generous paid time off and holidays
    • Employee Assistance Program

Optional Benefits:

  • Voluntary Life and AD&D for employee & family
  • Supplemental Medical Coverage (Critical Illness, Hospital Indemnity, and Accident Coverage)
  • Pet Insurance
  • ID Theft Protection
  • PerkSpot Discount Program

How to Apply:
If you are looking for a dynamic and rewarding career, we invite you to apply today! Please visit Jubilant Careers and select the Spokane, WA location.


Jubilant HollisterStier is an Equal Opportunity Employer (EEO/AA).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require assistance with your application, please contact our HR Department at:
Human.Resources@jubl.com