QA Auditor Pharmaceutical

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.

Job Title: QA Auditor Pharmaceutical

Location: Paramus, NJ, 07652

Job Type: Temporary Assignment

Duration: 5+ Months

Work Type: Onsite

Shift: 9.00AM-5.00PM

Job Description:

Summary:

• The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards.
• This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes.

Key Responsibilities

• Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers.

• Prepare detailed audit plans, checklists, and schedules.

• Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines.

• Review and approve deviations, CAPAs, and change controls.

• Document audit observations and issue formal audit reports.

• Track and verify implementation of corrective and preventive actions (CAPAs).

• Provide guidance on compliance requirements and audit readiness.

• Support regulatory inspections and customer audits.

• Identify systemic issues and recommend process improvements.

• Stay updated on evolving regulatory requirements and industry best practices.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or related field.

• 3 5 years in Radio Pharmaceuticals, with at least 2 years in auditing.

• Strong knowledge of RPT cGMP, GDP, and global regulatory requirements.

• Excellent attention to detail and analytical skills.

• Strong communication and report-writing abilities.

• Ability to travel (up to 10%) for audits.

Preferred Certifications

• ASQ Certified Quality Auditor (CQA)

• ISO 9001 Lead Auditor

• GCP/GMP auditing certifications

TekWissen Group is an equal opportunity employer supporting workforce diversity.