• QA Audit Lead

    ThermoFisher Scientific (Middletown, VA)


    Work Schedule

     

    First Shift (Days)

     

    Environmental Conditions

     

    Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

    Job Description

    The QA Audit Lead is responsible for leading the QA Audit teams to ensure compliance with regulatory, corporate, and site requirements. This role involves representing the QA Audit team in cross-functional meetings, leading process improvement initiatives, and maintaining effective systems and metrics to demonstrate the effectiveness of QA Audit processes. The Batch Record Reviewer Lead ensures that all diagnostic products released for sale are documented as manufactured under compliant conditions and maintains an effective tracking and retrieval system for all manufacturing and QA evaluation records.

    Key Responsibilities:

    + **Leadership:**

    + Overseeing and leading the QA Audit teams.

    + Coordinate the training and cross-training of team members to ensure career development.

    + Set goals, conduct performance evaluations, provide improvement plans, and participate in disciplinary actions as required by the manager and HR.

    + **Compliance and Systems Management:**

    + Ensure systems are established, effective, and maintained in compliance with regulatory, corporate, and site requirements.

    + Represent the QA Audit team in cross-functional meetings and process improvement teams.

    + Identify, lead, and implement initiatives for the continual improvement of QA Audit and SAP processes.

    + **Metrics and Reporting:**

    + Develop, implement, monitor, and maintain meaningful metrics to demonstrate the effectiveness of QA Audit processes.

    + **Product Release Documentation:**

    + Ensure all diagnostic products released for sale are documented as manufactured under conditions in agreement with corporate, divisional, and regulatory requirements.

    + Maintain an effective tracking and retrieval system for all records pertaining to product manufacturing and QA evaluation, including batch record archival.

    + **GMP Batch Audits:**

    + Conduct thorough GMP batch audits of Middletown product manufacturing records, including yield reconciliation, conformity to existing QA and manufacturing procedures, conformity to Product Master Records, lot number identification, expiration dating, and deviation documentation.

    + **Organizational Flexibility:**

    + Develop and maintain a flexible organization to accommodate fast-changing manufacturing priorities with minimal disruption.

    + **SAP Administration:**

    + Perform SAP Administrator functions as required.

    Qualifications:

    + Proven experience in a role with simular responsibilities within a manufacturing environment.

    + Strong understanding of regulatory, corporate, and site requirements.

    + Excellent leadership and team management skills.

    + Proficiency in SAP and other relevant software.

    + Strong analytical and problem-solving abilities.

    + Excellent communication and interpersonal skills.

     

    This position requires a proactive individual with a strong commitment to quality and compliance, capable of leading a team to achieve high standards in QA Audit processes.

     

    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.