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Lancaster

    Quality Assurance Specialist - Lancaster, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Lancaster, United States

    4 weeks ago

    Default job background
    Description
    Responsibilities:
    • Quality Assurance Specialists working in one of our distribution centers are responsible for enforcing our cGMP practices on-site.
    • Report any concerns or opportunities for improvement to the QA Safety & Facilities Manager.
    • Provide cGMP and controlled document training for new hires and refresher training annually for all warehouse departments and maintain training records.
    • Assist employees in submitting quality assurance policies and cGMP procedures.
    • Assist departments with coordinating audit information and recommend appropriate data-gathering mechanisms, procedures, etc.
    • Is familiar with cGMP standards and/or ISO certification in the same or related industry.
    • Document control expert for revision control, processing, and filing (hard copy and electronic).
    • Maintain Excel tracking logs and create matrix and reports to assist the Compliance Manager in evaluating trends.
    • Work with the Returns team on any customer complaint returns or undeliverable packages.
    • Perform daily and monthly DC audits/inspections and ensure any corrective actions from audits are closed.
    • Responsible for knowing current QA regulations pertinent to the dietary supplement industry and training and enforcing regulations within the distribution center.
    • Perform internal audits at the distribution center as required and ensure preparedness for regulatory on-site audits.
    • Assist the Senior Manager of Quality with managing quality issues such as product recalls, CAPAs, deviations, and adverse event reporting.
    • Maintain current and accurate records of all relevant communications, audits, corrective action plans, preventative maintenance, and effectiveness monitoring.
    • Perform other assigned duties as necessary within the realm of the Quality department.
    • Work independently in an on-site (not a hybrid/remote) role.

    Requirements:

    • Detail-oriented, organizational, and investigative qualities essential
    • Focused and self-starter mentality.
    • Excellent verbal and written communication skills
    • Interpersonal skills for successful interaction with company employees at all levels and possibly regulatory authorities
    • Expertise in using Microsoft programs (Word, Excel, PowerPoint).
    • Familiar with cGMP standards and/or ISO certification in the same or related industry.
    • Experience with an Inventory ERP system is a plus.
    • Associate degree required; Bachelor's degree preferred.
    • 2-3 plus years of related quality coordination experience in the same or related regulated industry.
    • Ability to work independently within the warehouse environment.
    • Comfortable dealing with upper management, auditors, etc.
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