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    Quality Control Laboratory Technician

    Jubilant Pharma
    1-2 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: Quality Control Laboratory Technician (Temporary position – 12 months)

    Schedule: Monday to Friday
    Shift: Day

    Location: Jubilant Radiopharma

    About Jubilant Radiopharma:

    At Jubilant Radiopharma, we are committed to making a significant impact on patients’ lives by providing high-quality radiopharmaceutical products. As an industry leader, we offer exciting opportunities for professional growth and development in a collaborative work environment where your contributions are valued and recognized.

    Job Summary:

    The Quality Control Laboratory Technician will be responsible for performing chemical and physical analyses on radioactive and non-radioactive samples in compliance with established protocols, good manufacturing practices (GMP), and internal procedures. The role involves conducting testing on various products and materials such as finished products, lyophilized kits, raw materials, and packaging components, ensuring that all tests are executed accurately, results are documented properly, and any irregularities are promptly addressed.

    Key Responsibilities:

    • Perform chemical and physical analyses on assigned samples (finished products, lyophilized kits, raw materials, packaging components, stability, and validation) following established specifications, methods, and procedures.
    • Participate in product and equipment validation (providing technical support).
    • Perform verification and calibration of laboratory equipment as needed.
    • Provide technical assistance with analytical methods used in the laboratory.
    • Execute analytical protocols and maintain high levels of accuracy and consistency in testing.
    • Monitor the radioactive laboratory daily (Lab Survey) and conduct weekly monitoring (Wipe Tests).
    • Manage stability samples for raw materials and finished products by removing them from storage as necessary.
    • Sample raw materials, packaging components, intermediate products, and finished products for testing.
    • Receive and inspect incoming raw materials to ensure quality standards.
    • Coordinate testing efforts with external laboratories when required.
    • Verify labeling and packaging components (e.g., vials, caps, etc.).
    • Perform radiochemical purity tests on lyophilized kits.
    • Ensure proper documentation of all test results, instrument readings, and observations, maintaining data integrity and traceability as per GMP standards.
    • Keep work areas clean and maintain a safe laboratory environment.
    • Notify the supervisor immediately upon discovery of any out-of-spec, out-of-trend, or incomplete analysis results, and assist in the investigation of issues.
    • Perform related tasks as assigned by the Quality Control Supervisor, such as document verification/revision, equipment maintenance, cleaning, troubleshooting minor analytical issues, and data collection for APQR (Annual Product Quality Review).
    • Undertake any other duties as requested by management.

    Qualifications:

    • Education:
      Technical D.E.C. in Analytical Chemistry, Chemical-Biology, Biotechnology, or a Bachelor’s degree in Chemistry, Biochemistry, or related fields.

    • Experience:
      1 to 2 years of experience in a quality control laboratory within the pharmaceutical industry.

    • Skills:

      • Strong knowledge of Good Manufacturing Practices (GMP) and pharmacopoeias (USP, Ph. Eur., BP) and their application in a laboratory setting.
      • Hands-on experience with analytical techniques such as HPLC, GC, AA, spectrophotometry, infrared analysis, and wet chemistry.
      • Familiarity with computer software (Microsoft Office, SAP, and data acquisition systems).
      • Bilingual: Proficient in both French (oral and written) and functional English (reading and writing).
      • Excellent technical writing skills and attention to detail.
      • Strong analytical abilities and problem-solving skills.
      • Ability to work under pressure, prioritize tasks, and meet deadlines.

    Why Join Us?

    • Exciting opportunity to grow professionally in the radiopharmaceutical industry.
    • Collaborative work culture where your contributions are recognized.
    • Competitive salary and benefits.

    Jubilant Radiopharma is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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