QA Auditor Pharmaceutical

Paramus, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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

Bachelors 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.

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 Wor...