QA Auditor II

QA Auditor II - Whitehouse, NJ

Intertek is searching for a QA Auditor II to join our Chemicals & Pharmaceuticalsteam in our Whitehouse, NJ office.

This is a fantastic opportunity to grow a versatile career in Quality Assurance.

Intertek's Chemical & Pharmaceuticals team brings quality and safety to life through regulatory guidance and supply chain assurance to support your unique pharmaceutical or biopharmaceutical outsourcing requirements.

Over the last 20 years, our network of laboratories and regulatory experts have provided high quality custom pharmaceutical services ensuring Total Quality Assurance for some of the world's largest and most innovative pharmaceutical companies.

Intertek is continually innovating and evolving to reduce risk for consumers, brands and organizations in every sector and industry around the world.

We go beyond Testing, Inspection and Certification of products: we are a Total Quality Assurance Provider to industries worldwide.

Our Purpose: Bringing quality, safety, and sustainability to life.

What are we looking for?

The QA Auditor II is responsible for ensuring that analytical data generated meets company standards and regulatory requirements (US FDA, US DEA and EMA regulations).

Salary & Benefits Information

The base wage or salary range for this position is $70,000-$95,000.

Individual compensation packages are based on a variety of factors unique to each candidate including skill set, experience, qualifications, and other job-related reasons.

This position is bonus eligible.

In addition to competitive compensation packages, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more.

What you'll do:


* Review all tests results, raw data including electronic data generated in support client sample testing, utilizing but not limited to the following industry technologies.


* Review/approval of GMP Analytical Reports and associated electronic and hard copy data, audit trails and notebooks to ensure:
+ Accuracy and completeness of data including system suitability
+ Reagents, standards, and equipment used are within the acceptance range.
+ The correct samples were run and methods were performed as intended.
+ Calculations are correct
+ Electronic data audit trails and instrument logs on cGMP instrumentation and equipment are reviewed for accuracy and approved for data release.


* Review and release of cGMP reports including validation, transfer, method development/optimization, release, and stability reports.


* Ensure analyst follow all SOPs, good documentation practices (GDP) and cGMP requirements.


* Ensure project notebooks and data are reviewed promptly, in accordance with SOPs.


* Work with analysts for document corrections and provide guidance accordingly.

on SOP and good documentation practi...