Quality Assurance Auditor

2 weeks ago

Lancaster, United States Nutramaxlabs Laboratories Full time
Job Overview

Position Summary

The Quality Assurance Auditor plays a pivotal role within Nutramax Laboratories, reporting directly to the Director of Quality. This position is essential for the development and maintenance of a robust Internal Compliance program, ensuring adherence to relevant regulations. The Auditor is tasked with conducting both internal and external audits, managing audit schedules, and addressing corrective actions based on identified findings.

Key Responsibilities

  • Oversee the planning, scheduling, and execution of internal and external audits to evaluate compliance with regulatory standards.
  • Conduct audits of external suppliers and manage the vendor qualification program, including maintaining the Approved Vendor List.
  • Supervise external vendors responsible for international audit processes.
  • Administer the Supplier Corrective Action Request (SCAR) program.
  • Maintain comprehensive documentation related to audits, vendors, and suppliers within a Quality Management System (QMS).
  • Assess the risk associated with audit findings and ensure effective follow-up on corrective actions, addressing both immediate corrections and preventive measures.
  • Develop and implement a system for tracking performance and reporting on departmental compliance.
  • Prioritize tasks to ensure timely completion of audits and reports, supporting the implementation of Corrective and Preventive Action (CAPA) programs as necessary.
  • Provide training and support to internal departments to foster understanding and compliance with Quality and Compliance standards.
  • Evaluate the internal audit process by identifying high-risk areas and assisting in the development or execution of policies to mitigate those risks.
  • Prepare teams for regulatory inspections through effective training and readiness initiatives.
  • Collaborate with other members of the Quality Assurance team to enhance overall effectiveness.
  • Report audit metrics to Quality Assurance and departmental management.
  • Communicate effectively across all organizational levels and foster a collaborative team environment.
  • Understand the roles and responsibilities of Contract Manufacturing Organizations, providing necessary Quality Assurance support.
  • Review and approve batch records from Contract Manufacturing Organizations and assist with in-house batch releases as required.
  • Utilize QA functions within SAP as needed.
  • Perform additional duties as assigned to meet Quality Assurance and company objectives.

Qualifications

  • A minimum of 5 years of experience in Quality Assurance auditing within a cGMP environment, including at least 5 years of external vendor compliance auditing experience in an FDA-regulated industry.
  • In-depth knowledge of regulations including 21 CFR Parts 210, 211, 507, and Dietary Supplement Regulations 21 CFR 111.
  • ASQ Certified Auditor (CQA) certification is preferred.
  • Proficiency in computer software applications, particularly the MS Office suite.
  • Ability to stand, walk, push, and pull in various environments, including manufacturing and clean rooms, while adhering to Personal Protective Equipment (PPE) requirements. Willingness to travel for domestic audits, with potential for international travel as needed.

Education

Bachelor's degree in a Science or Technical field is required.

Supervisory Responsibilities

None

Job Posted by ApplicantPro

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