QC Stability Study Coordinator I - Vacaville - VIVOS Professional Services, LLC

    VIVOS Professional Services, LLC
    VIVOS Professional Services, LLC Vacaville

    1 day ago

    Description

    Job Title: QC Stability Study Coordinator I

    Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.

    Location: Vacaville, CA (Onsite)

    Pay Rate: $27.93 per hour

    Job Summary

    Under limited supervision, the QC Stability Study Coordinator I is responsible for managing stability programs in compliance with Current Good Manufacturing Practice (cGMP) regulations. This role includes stability protocol coordination, data trend analysis, documentation review, deviation support (OOS, OOT, OOE), and stability study execution.

    The coordinator works closely with Quality Control leadership and cross-functional teams to ensure data integrity, regulatory compliance, and timely completion of stability activities.

    Key Responsibilities

    Stability Program Management

    • Coordinate and oversee stability study activities in compliance with cGMP requirements
    • Create and maintain stability protocols and related documentation
    • Support stability deviation investigations and assessments
    • Assist with time point approvals and stability study execution
    • Participate in stability-related projects and continuous improvement initiatives

    Data Review & Analysis

    • Review stability data against established acceptance criteria
    • Perform technical review of peer-generated data
    • Conduct routine and non-routine Out-of-Trend (OOT) and linear regression assessments
    • Identify discrepancies and support quality investigations and CAPA activities
    • Generate stability data tables and support annual report requests

    Documentation & Compliance

    • Support Master Data Testing creation and review
    • Assist with change control and document management processes
    • Support Annual Product Quality Reviews (APQR) authoring activities
    • Ensure compliance with cGMP, SOPs, and regulatory requirements
    • Support internal audits, external audits, and regulatory inspections

    Operational & Quality Support

    • Maintain compliance of QC operational areas
    • Assist with training coordination and documentation
    • Perform stability-related data entry and verification
    • Coordinate with internal teams and customers to support multi-site operations

    Continuous Improvement

    • Identify gaps in systems and procedures and recommend improvements
    • Support timelines, project deliverables, and departmental goals
    • Participate in xhmxlyz quality and stability-related improvement initiatives

    Required Qualifications

    • Bachelor's degree (B.S. / B.A.) in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field
    • 1–3 years of experience in pharmaceutical, biotechnology, or regulated laboratory environment, or equivalent combination of education and experience

    Required Skills

    • Knowledge of cGMP regulations
    • Strong analytical and problem-solving skills
    • Experience with stability programs, QC laboratory processes, or data review preferred
    • Strong written and verbal communication skills
    • Ability to work independently with limited supervision
    • Strong organizational and time management skills
    • Proficiency with Microsoft Office and quality systems
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