QA Auditor II

Intertek•Whitehouse, NJ

13h•Onsite

About The Position

Intertek is searching for a QA Auditor II to join their Chemicals & Pharmaceuticals team in their Whitehouse, NJ office. This role offers a fantastic opportunity to grow a versatile career in Quality Assurance. The Chemicals & Pharmaceuticals team provides regulatory guidance and supply chain assurance to support pharmaceutical or biopharmaceutical outsourcing requirements. With over 20 years of experience, their network of laboratories and regulatory experts have delivered high-quality custom pharmaceutical services, ensuring Total Quality Assurance for major pharmaceutical companies. Intertek is dedicated to innovation and risk reduction for consumers, brands, and organizations globally, functioning as a Total Quality Assurance Provider. Their purpose is to bring quality, safety, and sustainability to life.

Requirements

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

Nice To Haves

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

Responsibilities

Ensuring that analytical data generated meets company standards and regulatory requirements (US FDA, US DEA and EMA regulations).
Review all tests results, raw data including electronic data generated in support client sample testing.
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, and that the correct samples were run and methods were performed as intended.
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.