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Stability Associate

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: Stability Associate
Location: Spokane, WA
Company: Jubilant HollisterStier LLC
Function: Quality Control (QC)
Shift: Day Shift


Job Description

Jubilant HollisterStier LLC, a well-established leader in the pharmaceutical and biopharmaceutical industries, is currently seeking a Stability Associate to join our team in Spokane, Washington. We provide a comprehensive range of services to support the pharmaceutical and biopharmaceutical sectors, including the manufacture of allergenic extracts, sterile injectable vials, and lyophilized products. As a proud member of the Jubilant Pharma family, we are committed to delivering value through innovative products and cost-effective solutions.


Key Responsibilities

  • Stability Program Management: Implement and maintain stability testing programs for all products requiring such studies.
  • Study Initiation: Ensure stability batches are provided to the stability department in a timely manner, and studies are initiated as required by protocols or SOPs.
  • Data Entry & Review: Enter stability data into the Stability LIMS System and review the data for accuracy and completeness.
  • Reporting: Prepare and submit required reports, including Annual Reviews, DMFs, and client product reports, or as requested.
  • Communication: Document and communicate significant events during stability studies to internal and external stakeholders.
  • Sample Custody: Maintain accurate inventory and clear chain of custody for stability samples.
  • Study Closure: Review and close out completed or cancelled studies in accordance with the required procedures.
  • SOP Development: Revise or create new Standard Operating Procedures (SOPs) as needed to document stability department processes.
  • Special Projects: Conduct special projects such as summarizing product deviations, failures, or process changes, and assist with deviation investigations.
  • Collaboration: Work with the QC Stability Supervisor, facilities maintenance, business development, process development, and other personnel to ensure proper stability sample storage space is available.
  • Compliance Assistance: Assist with activities to ensure compliance in the Stability areas, including actions related to temperature/humidity excursions in stability chambers.

Qualifications

  • Education: High School diploma or equivalent with 2+ years of experience in a pharmaceutical or FDA-regulated industry. A Bachelor’s Degree is preferred.
  • Experience: No prior stability experience required. Understanding of cGMP concepts related to stability studies and quality is desired.
  • Knowledge: Familiarity with FDA and ICH guidelines for conducting stability studies is a plus.
  • Technical Skills: Basic understanding of various computer programs for database management and data evaluation. Proficiency in MS Word and Excel is required.
  • Physical Requirements: Ability to lift up to 25 lbs.

Compensation & Benefits

  • Hiring Wage: $27.01 – $36.53/hr (depending on experience), with opportunities for growth, promotion, and annual raises.
  • Benefits:
    • Medical, Dental, Vision, and Flexible Spending & 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 & AD&D for employees & family
    • Supplemental medical coverage (Critical Illness, Hospital Indemnity, Accident)
    • Pet Insurance
    • ID Theft Protection
    • Perk Spot Discount Program

Why Join Us?

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic, rewarding career with opportunities for growth and advancement, apply today!

How to Apply:
Visit our career portal at Jubilant HollisterStier Careers and select the Spokane, WA link to apply.


Equal Opportunity Employer
Jubilant HollisterStier is an EEO/AA 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.

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