Eurofins BioPharma Product Testing North America ยท 1 day ago
Quality Assurance Auditor
South Brunswick, NJ
Full-time
Onsite
New Grad, Entry Level
$22.50/hr - $25.50/hrEurofins Scientific is an international life sciences company providing analytical testing services across multiple industries. The Quality Assurance Auditor will assist in performance of Quality Assurance functions, conduct inspections, audit raw data, and update Standard Operating Procedures as required.
Biotechnology
Responsibilities
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
Qualification
Required
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
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
Preferred
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
Benefits
Comprehensive medical coverage, dental, and vision options.
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Company
Eurofins BioPharma Product Testing North America
Eurofins BioPharma Product Testing is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide providing comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase