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Quality Assurance Auditor
4 weeks ago
The Quality Assurance Auditor (QAA) plays a critical role in upholding the integrity of our quality systems and ensuring compliance with all applicable regulations and internal standards. This position is responsible for managing internal and external audit programs, vendor qualifications, and corrective/preventive action initiatives. The QAA will work cross-functionally to identify compliance risks, support regulatory readiness, and drive continuous improvement within the quality system.
Job Title: Quality Assurance Auditor
Job Type: Full-Time
Department: Quality Assurance
Reports To: Supplier Quality and Compliance Manager
Company CommitmentOur organization is committed to maintaining a drug-free, safe, and health-conscious workplace. We enforce a strict zero-tolerance policy for drug use. Employment is contingent upon the successful completion of a pre-employment background check, drug screening (in accordance with applicable laws), and a reading comprehension assessment.
Key Responsibilities- Audit Management: Plan, schedule, and execute internal and external audits to assess compliance with regulatory requirements.
- Audit of CMOs & vendor qualification: Conduct audits of contract manufacturing organizations (CMOs) and manage vendor qualification activities.
- Third-party audits: Oversee third-party vendors responsible for international audits.
- Documentation & QMS: Maintain the Approved Vendor List and all related documentation in the Quality Management System (QMS).
- SCAR program: Manage the Supplier Corrective Action Request (SCAR) program.
- CAPAs & risk: Assess audit findings for risk level and ensure timely and effective resolution of corrective and preventive actions (CAPAs).
- Product development & investigations: Support product development, investigations, and CAPAs related to supplier and CMO operations.
- Documentation & metrics: Maintain thorough records of audits, vendors, and supplier documentation. Develop and implement systems to track performance and report departmental compliance metrics. Support QA reporting to internal stakeholders and leadership teams.
- Training & support: Train internal departments on quality and compliance expectations. Assist in preparing for regulatory inspections and contribute to audit readiness initiatives. Provide ongoing support to the broader Quality Assurance team.
- Risk assessment & process improvement: Identify areas of potential non-compliance and recommend improvements to reduce risk. Support implementation of CAPAs and compliance-related process enhancements.
- Tools: Utilize enterprise software such as SAP, MS Office Suite, and Qualityze to manage quality data and workflows.
- Additional duties: Perform other duties as assigned in support of Quality Assurance and company objectives.
- Minimum of 5 years of Quality Assurance auditing experience in a cGMP-compliant environment.
- Minimum of 5 years of external vendor/supplier compliance auditing within an FDA-regulated industry.
- In-depth knowledge of applicable regulations, including:
- 21 CFR Parts 210, 211, and 507 (Pharmaceuticals)
- 21 CFR Part 111 (Dietary Supplements)
- Proficiency with computer software, including Microsoft Office, SAP, and electronic QMS platforms (e.g., Qualityze).
- Ability to stand, walk, push, and pull in manufacturing and cleanroom environments.
- Must be able to wear all required Personal Protective Equipment (PPE) based on audit environments.
- Willingness and ability to travel 20–30% domestically; occasional international travel may be required.
- ASQ Certified Quality Auditor (CQA) certification
- Experience with international vendor audits
- Familiarity with regulatory inspection readiness and FDA expectations
- Bachelor's degree (B.A. or B.S.) in a scientific or technical discipline is required.
- This position does not include supervisory responsibilities.
- Mid-Senior level
- Full-time
- Quality Assurance
- Pharmaceutical Manufacturing
