Quality Assurance Auditor

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

• Assist in performance of all Quality Assurance functions as outlined in the GLPs and PSL SOPs. Assist the Quality Assurance Director as needed during inspections by EPA, FDA or clients.  Prepare records and assemble copies of documents requested by inspectors when advance notice is given and Sponsor and/or Laboratory Director approval is obtained. 
• Conduct in-process study inspections and general facility inspections in the toxicology and chemistry laboratories as directed.
• Audit raw data and proofread report and tables against raw data for accuracy and for typing corrections.  Audit final report to verify corrections.
• Amend and update Standard Operating Procedures as required using word processing system. File all QAU-related paperwork as directed.
• Select intervals for inspection for any regulatory test under the auditor's responsibility or as directed by QA Director, Laboratory Director, or President.  Perform such inspections in accordance with the test schedule.  When the time for conduct of intervals requiring inspection falls outside of normal working hours, this will be brought to the attention of the Study Director or QA Director in order that a suitable arrangement may be made. 
• Ability to safely wear a respirator required.
• Other duties as assigned.

Qualifications

• QA auditors will have experience in a laboratory regulated by FDA/EPA GLP standards.  Experience in other quality standards such as cGMP or GCP will also be considered. 
• Experience with acute toxicology, analytical chemistry, and/or general laboratory procedures is preferred.  B.S. degree in biology, toxicology, animal science or related field and/or AALAS certification at the Technician level is also preferred.  Experience in computer system validation and electronic data capture is desirable but is not required.
• The individual holding this position must be of the highest integrity and have a very strong sense of responsibility.  Attention to detail is essential.  He/she must be well organized, tactful, be able to work independently and maintain all records, documents, and schedules associated with quality assurance procedures and studies.  Communication skills, especially written, are necessary.  Proficiency with MSWord and Excel is required.  He/she must have a current tetanus vaccination if required to access the vivarium.

Additional Information

Position is full-time, Monday-Friday 8am-5pm. Candidates within a commutable distance of South Brunswick, NJ are encouraged to apply.

Compensation: $22.50-$25.50/hr

Excellent Full-Time Benefits Including:

• Comprehensive medical coverage, dental, and vision options.
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.