JobDiva # 19-09013
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Data Reviewer for our client in New Brunswick, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview: The basic purpose of the Data Reviewer is to assure the quality of laboratory data and reports as specified in Standard Operating Procedures (SOPs), Work Instructions (WIs) and Methods. The Data Reviewer performs ongoing reviews of environmental monitoring (EM) and water system analytical results (Bacterial Endotoxin, Plate Count, TOC, Conductivity and other required compendial tests) to assure completeness of sampling procedures. Assists in compiling data necessary to complete quality investigations. Enters or reviews required data onto the Laboratory Information Management System (LIMS), when appropriate. Where appropriate authority assigned, may validate data on the Laboratory Information Management System. Sustains up to date knowledge on applicable department and site standard practices related to GMP’s, safety and controlled substances as appropriate to work.
The objective of the Data Reviewer is to assure compliance with SOP's, protocols, analytical methods and FDA's Good Laboratory Practices (GLP). The Data Reviewer interacts directly with laboratory personnel and management on routine matters; however, setting priorities and non-routine issues may require supervisory oversight. After completing initial training the Data Reviewer requires minimal supervision.
This position will serve as a Data Review Microbiologist in the Analytical Strategy and Operations (ASO) Microbiology Group. This position is responsible for reviewing all relevant data, notebooks, logbooks, etc.
- BS degree in Microbiology or a related scientific discipline with 3-5 years of experience.
- Knowledge of FDA's GLP or GMP (Good Manufacturing Practices) regulations are required
- Good verbal and written communication skills are necessary
- Have strong attention to detail
- Must be detail oriented and able to deal with changing priorities
- Experience in a GMP Microbiology laboratory is desired
- Possess a strong understanding of Word and Excel
- Experience with electronic notebooks
- Prior Data Review experience is a plus
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Paul Quibuyen | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Job Status: Contract/Temporary