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    Senior Quality Systems Specialist

    Cellares
    5+ years
    $90,000 - $210,000 a year
    Bridgewater
    10 July 16, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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: Senior Quality Systems Specialist

    Location: IDMO, Bridgewater, NJ

    Company: Cellares

    Job Overview:

    Cellares, the first Integrated Development and Manufacturing Organization (IDMO), is seeking an innovative and highly motivated Senior Quality Systems Specialist. The role is responsible for maintaining the Quality System within the requirements of FDA’s GMP regulations, managing eQMS day-to-day activities, and developing novel products in the cell and gene therapy world. This is a hands-on, on-site role in a fast-paced, mission-driven environment.

    Responsibilities:

    • eQMS Management:

      • Administer controls, configure systems, perform periodic upgrades, and drive continuous improvement efforts.
      • Maintain and improve quality system procedures and programs, including training programs and document control.
      • Manage the periodic review program of the eQMS.

    • Training Coordination:

      • Coordinate employee training, including onboarding to the QMS, daily training tasks, training plans, and training content.

    • Document Control:

      • Oversee document control processes within the eQMS, including reviewing document formatting, periodic document reviews, and training authors and approvers.
      • Maintain metadata integrity and submission of DCRs, ensuring compliance with local and corporate procedures.

    • System and Process Improvements:

      • Drive global system and process improvements, support administration of the Document Control system, process harmonization activities, system updates, and upgrades.

    • Audit and Inspection Support:

      • Support internal and external audits and client inspections, including backroom support.

    • Quality Metrics Development:

      • Develop quality system metrics for training programs, document control, productivity, and effectiveness, and present these during the Quality Management Review.

    • Promote Quality Environment:

      • Establish and promote an environment that supports the Quality Policy, Data Integrity, and Quality System.

    Requirements:

    • Educational Qualifications:

      • Bachelor's degree or higher in a relevant scientific discipline (Biotechnology, Biology, Biochemistry, or Chemistry).

    • Experience:

      • 5+ years of experience in a GMP environment.
      • Strong technical knowledge of cGMP regulations and eQMS systems (TrackWise Digital experience preferred).

    • Knowledge and Skills:

      • Strong working knowledge of quality systems and regulatory requirements, including 21 CFR Part 11/210/211.
      • Strong understanding of regulatory inspections and knowledge of their requirements.
      • Excellent interpersonal, verbal, and written communication skills.
      • Ability to build strong working relationships with cross-functional departments.
      • Comfortability in a fast-paced environment with minimal direction and ability to adjust to a dynamic work environment.
      • Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset.

    Compensation:

    • Salary Range: $90,000 - $210,000 a year (approximate, negotiable, and location dependent)
    • Benefits:
      • Competitive base salaries.
      • Highly subsidized Medical, Dental, and Vision Plans.
      • 401(k) Matching.
      • Free EV Charging.
      • Onsite lunches.
      • Stock options.

    About Cellares:

    Cellares is an Industry 4.0 company dedicated to mass manufacturing the living drugs of the 21st century. It integrates all necessary technologies for the cell therapy manufacturing process into a flexible, high-throughput platform called the Cell Shuttle, delivering true walk-away, end-to-end automation. Cellares’ Smart Factories are designed to meet global patient demand for cell therapies, lowering process failure rates and manufacturing costs. Cellares is headquartered in South San Francisco, California, with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

    Note: Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.

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