QA Auditor II

Intertek is searching for a QA Auditor II to join our Chemicals & Pharmaceuticals team in Whitehouse, NJ. This role offers a fantastic opportunity to grow a versatile career in Quality Assurance within a global leader in Total Quality Assurance.

About the role

The QA Auditor II ensures analytical data meets company standards and regulatory requirements (US FDA, US DEA, and EMA regulations). This position involves reviewing and approving GMP Analytical Reports, electronic and hard copy data, audit trails, and notebooks to guarantee accuracy, compliance, and adherence to good documentation practices (GDP) and cGMP requirements.

Responsibilities

• Review all test results and raw data, including electronic data generated in support of client sample testing, using industry technologies.
• Review and approve GMP Analytical Reports and associated data to ensure:
  • Accuracy and completeness of data, including system suitability.
  • Reagents, standards, and equipment are within acceptance ranges.
  • Correct samples were run and methods performed as intended.
  • Calculations are correct.
• Review and approve electronic data audit trails and instrument logs on cGMP instrumentation for data release.
• Review and release cGMP reports, including validation, transfer, method development/optimization, release, and stability reports.
• Ensure analysts follow all SOPs, GDP, and cGMP requirements.
• Review project notebooks and data promptly, in accordance with SOPs.
• Work with analysts for document corrections and provide guidance on SOP and GDP requirements.
• Review and approve internal records such as:
  • Instrument calibration and maintenance.
  • Training records.
  • Laboratory investigations (OOS/OOT, NCRs, Complaints).
  • Change Control and Internal audits.
• Review root cause analyses, risk assessments, 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 maintain a cGMP environment and safe practices.
• Assist and support internal, client, vendor, and regulatory audits.
• Assist in policy and procedure development.
• Support Corrective Actions Preventative Actions (CAPA) and DEA activities.
• Assist with monitoring and managing KPIs.
• Perform additional tasks as assigned by the QA Director.

Requirements

• BA/BS in Chemistry, Biology, or a related scientific field.
• Minimum of 4 years of related industry experience (ATIC) in a pharmaceutical or medical device analytical laboratory.
• Knowledge of laboratory safety precautions and protocols for handling hazardous agents, chemicals, and materials.
• Strong organization, communication, and analytical skills.
• Ability to understand and effectively communicate technical and business information, both orally and in writing.
• Intermediate mathematical skills.
• Awareness of and adherence to safety practices and policies.
• Ability to work in a fast-paced, multi-tasking environment with shifting priorities and demanding deadlines.
• Detail-oriented with strong prioritization, organization, and time management skills.
• Customer-focused and quality-driven.
• Ability to travel as business needs dictate.

Preferred Qualifications

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

Pay

The base wage or salary range for this position is $70,000–$95,000. Individual compensation packages are based on factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons. This position is bonus eligible.

Benefits

• Medical, dental, and vision insurance.
• Life and disability insurance.
• 401(k) with company match.
• Generous vacation and sick time (PTO).
• Tuition reimbursement.