QA Auditor II

QA Auditor II - Whitehouse NJ

Intertek is searching for aQA Auditor IIto join our Chemicals & Pharmaceuticalsteam in our Whitehouse NJoffice. This is a fantastic opportunity to grow a versatile career in Quality Assurance.

Interteks 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 worlds largest and most innovative pharmaceutical is continually innovating and evolving to reduce risk for consumers brands and organizations in every sector and industry around the go beyond Testing Inspection and Certification of products: we are a Total Quality Assurance Provider to industries Purpose: Bringing quality safety and sustainability to life.

What are we looking for

The QA Auditor IIis 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 $70000-$95000. 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 youll 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 practices (GDP) requirements.
• Review/approval of internal records such as: Instrument calibration and maintenance Training records Laboratory investigations OOS/OOT NCRs Complaints Change Control and Internal audits
• Review of root cause analyses risk assessments and analyses corrective and preventive actions (CAPA) and effectiveness checks
• Ensure compliance with US FDA US DEA and EMA regulations
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
• Assists and support with internal client vendor and regulatory audits
• Assists and support with policy and procedure development
• Assists and support for Corrective Actions Preventative Actions (CAPA)
• Assists and support for DEA activities
• Assist and support with monitoring and managing KPIs.
• Perform additional tasks as assigned by the QA Director

This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties.

Minimum Requirements & Qualifications:

• BA/BS Chemistry Biology or related scientific degree
• Minimum of 4 years of related industry experience (ATIC) in a related analytical laboratory (pharmaceutical or medical device)
• Knowledge of laboratory safety precautions and protocols for safe handling and the disposal of hazardous agents/ reagents chemicals and materials
• Organization communication and analytical skills
• Ability to understand and effectively communicate technical and business information both oral and written to others including co-workers supervisors subordinates clients and vendors
• Ability to define problems collect data establish facts and draw valid conclusions
• Intermediate mathematical skills
• Be aware of and adhere to safety practices and policies to ensure your own safety as well as the safety of others who may be affected by your actions at work
• Ability to work in fast-paced multi-tasking environment with shifting priorities and demanding deadlines
• Must be detailed-oriented and able to effectively prioritize and organize workload with efficient time management
• Ability to communicate and interact effectively in verbal written and presentation formats
• Must possess the fundamental technical and administrative skills required to perform the job duties
• Must be customer focused and quality driven
• Ability to travel as business needs dictate

Preferred Requirements and Qualifications:

• Previous experience using and or reviewing data from analytical instrumentation and including: HPLC LC-MS GC GC-MS ICP ICP-MS UV

Intertek: Total Quality. Assured.

Intertek is a world leader in the Quality Assurance market with a proven high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. With passion pace and precision we work to exceed our customers expectations while engaging with our employees to be 10X in their performance and professional growth.

Intertek is a drug-free workplace. As a condition of employment certain positions may be required to pass a pre-employment drug test based on the type of work that will be performed.

We Value Diversity

Interteks network of phenomenal peopleare our greatest assets and the diversity they bring fuels our success. Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity. We take affirmative action to ensure all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability veteran status or other legally protected characteristics.

For individuals with disabilities who would like to request accommodation or who need assistance applying please email or call 1- (option #5) to speak with a member of the HR Department.

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*Intertek does not accept unsolicited approaches from agencies and will not pay a fee for any placement resulting from the receipt of an unsolicited resume