Quality Compliance Auditor I

We’re Hiring a Quality Compliance Auditor I

Overview:

Join our team at Plexus Worldwide as a Quality Compliance Auditor and play a critical role in ensuring our suppliers and distributors uphold the highest standards of Good Manufacturing Practices (GMP), government regulations, and our internal quality benchmarks. Your expertise in auditing, compliance, and quality improvement will drive our commitment to product integrity and regulatory excellence. Reporting directly to our Quality Assurance leadership, this role offers a unique opportunity to make a meaningful impact on our global quality initiatives.

Employee Value Proposition:

Become part of a dynamic organization that values innovation, collaboration, and continuous improvement. This role offers a chance to work closely with cross-functional teams and external partners while enhancing your career through exposure to industry-leading practices and quality systems.

Key Performance Objectives (KPOs):

• Conduct High-Impact GMP Audits:
  • Assess and audit supplier and distributor facilities to ensure compliance with FDA regulations, GMP certifications, and Plexus standards.
  • Effectiveness will be measured by the identification and resolution of non-compliance issues and the implementation of corrective action plans (CAPAs).
• Enhance Quality Systems and Processes:
  • Assist in improving SOPs, risk-based auditing processes, and training programs to strengthen compliance across the supply chain.
  • Success will be demonstrated through improved audit scores and consistent adherence to updated procedures.
• Foster Supplier and Distributor Partnerships:
  • Build collaborative relationships with suppliers and distributors to share best practices and drive continuous improvement initiatives.
  • Achievements will include measurable quality improvements and stronger supplier partnerships.
• Ensure Regulatory Readiness:
  • Support internal teams in preparing for regulatory inspections and audits.
  • Success will be indicated by compliance with FDA 21 CFR Part 111/117, MoCRA, OTC and effective regulatory inspections with minimal findings.

Essential Functions:

• GMP Audits: Conduct supplier and facility audits according to government regulations, third-party GMP certifications, and Plexus quality standards.
• Risk Assessment: Identify high-risk areas for non-compliance and develop targeted strategies to mitigate risks.
• Quality Improvement: Support the development of SOPs, quality systems, and continuous improvement initiatives to enhance compliance and operational efficiency.
• Collaboration: Partner with procurement, supply chain, and other internal teams to standardize supplier compliance audits and drive process improvements.
• Regulatory Expertise: Stay updated on relevant regulations and industry best practices, ensuring compliance across all touchpoints.
• Training & Development: Deliver training on quality topics and deploy revised quality system processes to internal teams.
• Documentation & Reporting: Maintain accurate quality databases and ensure timely and detailed reporting of compliance trends.
• Travel: Conduct site visits and audits, with travel required up to 20% of the time.

Performance-Based Qualifications:

• Educational Foundation: Associate degree in science-related fields (required); Bachelor’s degree in microbiology, chemistry, pharmacy, engineering, or related sciences (preferred).
• GMP Expertise: Minimum of 2 years of experience in GMP compliance in dietary supplements, pharmaceuticals, or skin care manufacturing.
• Audit Proficiency: At least 1 year of experience conducting audits with a proven track record of identifying risks and implementing CAPAs.
• Industry Certifications: Preferred certifications include ASQ Certified Quality Auditor, Food Safety and Quality Auditor (CFSQA), or Preventive Controls Qualified Individual (PCQI).
• Critical Skills:
  • Strong interpersonal skills for diplomacy and collaboration.
  • Practical judgment in interpreting FDA GMP regulations.
  • Proven ability to identify compliance risks and drive process improvements.
  • Adaptability and resilience in dynamic work environments.
  • High attention to detail in documentation and process reviews.

Thank you for taking the time to apply for an opportunity with our One Plexus team! If you had any issues during the application process, please contact us directly at [email protected].

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