Sr. Auditor Quality Assurance (Pharmaceuticals)

Location: Paramus, NJ (100% On-Site) - 5 month contract
Experience Level: Mid-Senior
Experience Required: 5+ Years
Education Required: Bachelors Degree (Life Sciences or related field)
Industry: Pharmaceuticals / Life Sciences
Job Function: Quality Assurance / Auditing / Compliance
Compensation: Hourly Competitive (rate provided upon request)
️ Relocation Assistance: Not Provided
Visa Sponsorship: Not Available

Position Summary

We are seeking a Senior Quality Assurance Auditor with strong experience in the pharmaceutical or radiopharmaceutical sector. This role is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with GMP, GDP, and other global regulatory standards. The successful candidate will play a critical role in upholding our Pharmaceutical Quality System (PQS) and ensuring inspection readiness across operations.

Key Responsibilities

• Conduct internal audits, supplier audits, and contract manufacturer (CMO) audits including routine, for-cause, and risk-based.

• Develop and manage audit plans, schedules, and checklists based on regulatory guidelines and internal SOPs.

• Assess compliance with FDA, EMA, ICH, and international GMP/GDP regulations.

• Review and evaluate deviations, CAPAs, and change control records.

• Generate detailed audit reports and communicate findings to internal and external stakeholders.

• Track CAPA implementation and verify effectiveness through follow-up assessments.

• Support regulatory authority inspections and third-party audits.

• Provide expertise on quality and compliance-related matters, promoting audit readiness culture.

• Identify systemic gaps, recommend improvements, and drive continuous quality improvement initiatives.

• Stay current on regulatory changes, industry trends, and quality system best practices.

Required Qualifications

Bachelors degree in Life Sciences, Pharmacy, or a closely related field
5+ years of pharmaceutical QA experience (with at least 2 years conducting audits)
Proven understanding of GMP, GDP, and radiopharmaceutical (RPT) compliance
Familiarity with global regulations including FDA, EMA, ICH
Excellent documentation, communication, and analytical skills
Ability to travel up to 10% for audits (domestic and potentially international)

Preferred Certifications

⭐ ASQ Certified Quality Auditor (CQA)
⭐ ISO 9001 Lead Auditor Certification
⭐ GCP/GMP Auditing Certifications

Why You Should Apply

If you're looking to leverage your audit and compliance skills in a growing, highly specialized sector like radiopharmaceuticals, this role offers the ideal opportunity. You'll work in a critical QA function with visibility across manufacturing, testing, and supply chain operations, helping to uphold product integrity and patient safety.

This is a high-impact position where your attention to detail and regulatory expertise will directly contribute to maintaining compliance, improving systems, and supporting global quality standards. Whether you're looking to step into a senior auditing role or expand your influence across a broader QA landscape, this opportunity provides the structure, challenge, and responsibility to help elevate your career.

Apply now to join a team committed to excellence in pharmaceutical quality and make a difference in the future of healthcare.