Job Number: 21-13001
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Failure Investigator for our client in Carlsbad, CA.
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!
- Determines the root cause and corrective action for deviations identified in various production processes.
- Ensures that investigations identify true root cause and appropriate corrective actions in order to prevent recurrence.
- In this role you will provide technical expertise within the context of defining the problem statement, assessing the impact, identifying root cause, and determining corrective actions, communicate cross-functionally effectively and professionally to lead investigative discussions, work independently and as part of a team to manage multiple projects simultaneously.
- You will need to have the ability to distill complex thoughts and issues so that an educated, but unfamiliar reader can understand and make decisions based on the written investigation report, be organized and detail oriented as well as an active listener and communicator.
- Bachelor's degree in life sciences or related scientific discipline
- 2+ years' experience in regulated environment
- Experience with CAPA's highly preferred
- Experience with deviation tracking system (e.g. Trackwise) and conducting investigations highly preferred
- Thorough understanding of the biopharmaceutical manufacturing process, current Good Manufacturing Practices highly preferred
- Experience working with quality tools (Fishbone Diagrams, 5 Whys, etc.)
- Good analysis, troubleshooting, investigation and communication skills, both written and verbal
- Must have knowledge on production facility language/ experience to know how to investigate it
- Interacting skills, writing Quality Systems
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:
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.