QA Auditor II - 2nd Shift

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

The QA Auditor is responsible for ensuring that all products are manufactured and released in compliance with regulatory, corporate, and site requirements. This role involves conducting thorough audits of manufacturing records, identifying areas for improvement, and maintaining accurate documentation. The QA Auditor plays a critical role in maintaining the quality and integrity of the manufacturing process.

Hours: Sun.-Thurs. 4p-10p

Key Responsibilities:

• Audit Execution:

  • Conduct thorough GMP batch audits of 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.
  • Ensure all diagnostic products released for sale are documented as manufactured under conditions in agreement with corporate, divisional, and regulatory requirements.

• Compliance and Documentation:

  • Maintain an effective tracking and retrieval system for all records pertaining to product manufacturing and QA evaluation, including batch record archival.
  • Ensure proper documentation and record-keeping practices are followed.

• Process Improvement:

  • Identify and implement initiatives for the continual improvement of QA Audit processes.
  • Develop, implement, monitor, and maintain meaningful metrics to demonstrate the effectiveness of QA Audit processes.

• Support and Collaboration:

  • Collaborate with the QA Audit team to ensure consistent and accurate audit processes.
  • Assist in the training and cross-training of team members to ensure career development.
  • Provide guidance and support to team members to enhance their skills and knowledge.

• Regulatory Compliance:

  • Ensure systems are established, effective, and maintained in compliance with regulatory, corporate, and site requirements.
  • Stay updated on regulatory changes and ensure compliance with new requirements.

Qualifications:

• HS Diploma or Equivelant required
• Ability to understand and implement the responsibilities of the QA Auditor role.
• Strong analytical and problem-solving skills.
• Proficiency in relevant software and systems.
• Excellent communication and interpersonal skills.
• Diligent with a strong commitment to quality and compliance.
• Ability to work collaboratively and support all team members.

This position requires an individual capable of understanding the responsibilities and completing the review processes to ensure high standards in QA Audit processes.