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Quality Assurance Specialist II

Katalyst Healthcares & Life Sciences

  • Oceanside, CA
  • 30+ days ago

    Highlights

    Bachelor's degree with 2+ years of experience, OR Master's degree, OR Associate degree with 4+ years of experience, OR High school diploma with 5+ years of relevant experience in biological sciences or a related field required. Job Summary: Quality Assurance Specialist II will provide hands-on support for production and quality operations, including batch record review, deviation management, and on-the-floor quality oversight.

    Numbers & Facts

    LocationOceanside, CA

    Description

    Job Summary:
    • Quality Assurance Specialist II will provide hands-on support for production and quality operations, including batch record review, deviation management, and on-the-floor quality oversight.
    • This role is responsible for ensuring product quality, regulatory compliance, and adherence to GMP requirements within a biopharmaceutical manufacturing environment.
    • The position supports quality systems, production activities, inspections, audits, documentation, and continuous compliance initiatives.
    Roles & Responsibilities:
    • Perform Quality Assurance activities including batch record review, line clearance, and on-the-floor production support.
    • Provide QA oversight and approval of Quality Control activities, including method transfers, Certificates of Analysis (CoA), and stability data.
    • Support and approve product shipments and packaging operations.
    • Ensure timely review and closure of deviations, discrepancies, CAPAs, change controls, and laboratory investigations.
    • Manage and resolve batch and material hold events in a timely manner.
    • Communicate lot disposition status and pending issues to management.
    • Conduct walkthroughs and process observations to ensure compliance with GMP standards.
    • Provide real-time QA oversight to ensure manufacturing operations adhere to regulatory and quality requirements.
    • Perform document control activities, including record archival and training documentation updates.
    • Support regulatory inspections and audits, including preparation and execution support.
    • Identify compliance risks and escalate issues as needed.
    • Author and update SOPs, procedures, and forms.
    • Perform additional duties as required to support quality and operational goals.
    Education & Experience:
    • Relevant experience in quality assurance, quality control, or GMP manufacturing environments.
    • Experience supporting deviation management, CAPA, and change control processes.
    • Familiarity with batch record review, product release, and QA oversight activities.
    • Experience working in regulated biopharmaceutical or life sciences environments.
    • Background in analytical, virological, or microbiological Quality Control testing.
    • Working knowledge of GMP standards aligned with U.S. and EU regulations.
    • Experience with systems such as Veeva, Smartsheet, and LIMS.
    • Bachelor's degree with 2+ years of experience, OR Master's degree, OR Associate degree with 4+ years of experience, OR High school diploma with 5+ years of relevant experience in biological sciences or a related field required.
    • Strong understanding of GMP compliance and quality systems.
    • Excellent attention to detail with a focus on accuracy and completeness.
    • Strong organizational and time management skills.
    • Effective communication and interpersonal skills in a collaborative environment.
    • Ability to identify risks and proactively escalate issues.
    • Strong problem-solving skills with the ability to manage complex quality scenarios.Flexibility to support weekend and off-hours work during manufacturing campaigns.
    • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

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