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    Environmental Monitoring (Em) Specialist

    Jubilant Pharma
    1-3 years
    Not Disclosed
    Remote, USA
    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: Environmental Monitoring (EM) Specialist

    Location: Spokane, WA
    Shift: Weekend Days (Friday – Sunday, 6:00 AM – 6:00 PM, and every other Thursday)

    Company Overview:
    Jubilant HollisterStier LLC, a member of the Jubilant Pharma family, is a leading global provider of pharmaceutical and biopharmaceutical services. Based in Spokane, WA, we specialize in manufacturing allergenic extracts for allergy and asthma treatments, along with sterile injectable vials and lyophilized products. Our mission is to deliver innovative solutions that enhance value for our customers and stakeholders while caring for the environment and society.

    Our Promise: Caring, Sharing, Growing

    Job Description:
    The Environmental Monitoring (EM) Specialist is responsible for overseeing EM functions and personnel, including the scheduling of tasks, assisting in the training of EM Technicians, and gown training of all aseptic personnel. The specialist will collect and evaluate data related to environmental quality parameters, ensuring the safety and compliance of aseptic areas and systems such as air, surface, personnel, and utility systems (e.g., compressed gases, WFI).

    Key Responsibilities:

    • Attain and maintain aseptic gown certification.
    • Collect and test samples within aseptic environments over extended periods (8-10 hours/day).
    • Operate appropriate monitoring sampling and testing equipment.
    • Prepare and autoclave supplies for sample collection and testing.
    • Enter and verify data in electronic spreadsheets for accuracy.
    • Write clear and concise observational memos and review results of testing.
    • Read, understand, and review Standard Operating Procedures (SOPs).
    • Analyze and trend environmental data to ensure compliance.
    • Schedule tasks and personnel for EM activities.
    • Train or schedule training for EM personnel and gown certification for aseptic entry.
    • Review HEPA filter records and issue QAMs, NCMRs, and Action/Alert notices.
    • Perform investigations and prepare related reports.
    • Write and review SOPs and protocols as required.
    • Provide backup support for EM Supervisor as needed.

    Qualifications:

    • Education:

      • Bachelor’s degree in Microbiology, Medical Technology, or related science with at least 1 year of experience in pharmaceutical or environmental monitoring, preferably in a lead position, OR
      • Associate’s degree or higher in Microbiology, Medical Technology, or related science with 2 years of pharmaceutical or laboratory experience, OR
      • Approximately 3 years of experience as an Environmental Monitoring Technician.

    • Experience:

      • Pharmaceutical and laboratory experience required.
      • Lead and FDA-regulated industry experience is highly desired.
      • Proficiency in MS Word and Excel required; experience with PowerPoint is a plus.
      • Familiarity with cGMP, CFRs, and guidelines is essential.
      • Mechanical aptitude and manual dexterity required.

    • Skills:

      • Strong written and verbal communication skills.
      • Ability to manage conflict and influence outcomes.
      • Ability to read and understand SOPs, and write clear, accurate memos.
      • Understanding of aseptic processing concepts.

    Physical Requirements:

    • Corrected near-point vision.
    • Ability to lift up to 25 lbs unassisted.
    • Exposure to allergens, working in aseptic areas, confined spaces, and repetitive activities.
    • Prolonged sitting and standing, and the ability to perform physical tasks such as pushing, pulling, and twisting.

    Compensation & Benefits:

    • Wage: $30.00 - $40.59 per hour depending on experience.
    • Shift Premium: 12% for the Weekend Day shift.
    • Benefits:
      • Medical, Dental, Vision, 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 coverages).
    • Pet Insurance.
    • ID Theft Protection.
    • Perk Spot Discount Program.

    How to Apply:
    To apply, please visit Jubilant HollisterStier Careers and click on the Spokane, WA link.

    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.

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

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