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Em Compliance Scientist Ii

2+ 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: EM Compliance Scientist II
Location: Spokane, WA
Shift: Day (Mon - Fri, 5x8)


Company Overview:
Jubilant HollisterStier LLC, part of the Jubilant Pharma family, is a well-established member of the Spokane business community. We provide a full range of services supporting the pharmaceutical and biopharmaceutical industries. Specializing in the manufacture of allergenic extracts and sterile injectable vials, we are also a recognized leader in lyophilized products.

Our Promise: Caring, Sharing, Growing
We strive to enhance value for our customers and stakeholders by providing innovative products and efficient solutions, focused on growth and sustainability.


Position Overview:
The EM Compliance Scientist II is responsible for the qualification, maintenance, repair, and compliance of laboratory instruments and software. This role requires a solid understanding of analytical instrumentation and the ability to troubleshoot issues, ensuring compliance with regulatory requirements. The ideal candidate will have knowledge in chemistry, statistics, computer-assisted data processing, and good manufacturing practices (GMP). Initiative and a willingness to learn are essential in this role.


Key Responsibilities:

  • Perform preventive maintenance and qualification activities on laboratory instrumentation as directed.
  • Ensure compliance with regulatory requirements by implementing appropriate operating system permissions on laboratory equipment.
  • Diagnose laboratory equipment issues and perform necessary repairs to maintain compliant functionality.
  • Prepare and review acceptance reports for laboratory equipment.
  • Complete core environmental monitoring (EM) training and adhere to plant safety programs, GMPs, and relevant regulations.
  • Ensure laboratory equipment performs accurately and confidently by maintaining and operating it properly.
  • Manage computer systems backups and ensure data integrity is maintained.
  • Create new procedures as needed to support compliance activities.
  • Participate in internal and/or external client interactions, providing support and ensuring compliance.
  • Lead or coordinate group projects related to laboratory compliance and equipment qualifications.
  • Perform additional assignments as directed by the Supervisor.

Qualifications:

  • Education: Associate of Science with an emphasis in Chemistry, Biology, or a related hard science required. Bachelor's degree preferred. Degree in a computer-related field is a plus.
  • Experience: Minimum of 2 years of relevant experience in a laboratory setting, preferably in an FDA-regulated industry.
  • Skills:
    • Proficiency in troubleshooting laboratory instruments.
    • Familiarity with Microsoft operating systems, software, and database configurations.
    • Strong skills in Microsoft Word and Excel.
    • Manual dexterity and ability to lift up to 25 lbs unassisted.
    • Near-point vision (20/30 corrected).
    • Ability to work in a dynamic, fast-paced environment.

Physical Requirements:

  • Ability to lift up to 25 lbs unassisted.
  • 20/30 corrected near-point vision.
  • Prolonged sitting/standing and repetitive activity.
  • Exposure to allergens.

Compensation & Benefits:

  • Wage: $30.00 - $40.59/hr, based on experience, with potential for growth and promotion.

  • Benefits:

    • Medical, dental, and vision coverage
    • Flexible Spending and Health Savings Accounts
    • Life, AD&D, Short and Long-Term Disability
    • 401(k) with company match
    • Generous paid time off
    • Employee Assistance Program
  • Optional Benefits:

    • Voluntary Life and AD&D for employee and family
    • Supplemental medical coverage (Critical Illness, Hospital Indemnity, and Accident)
    • Pet Insurance
    • ID Theft Protection
    • Perk Spot Discount Program

Why Join Us?
At Jubilant HollisterStier, we offer a dynamic and rewarding career with opportunities for growth, development, and long-term success. Join us to unlock your full potential in an innovative and supportive environment.


How to Apply:
Visit our careers page and click on the Spokane, WA link to apply today!

Equal Opportunity Employer:
Jubilant HollisterStier is an equal opportunity/affirmative action employer. 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.

Contact:
For assistance with the application process, please contact HR at Human.Resources@jubl.com.