Global Product Development and Supply - Deviation Investigator

Job Number: 26-00557

Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Global Product Development and Supply - Deviation Investigator for our client in Devens, MA.

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!

Responsibilities:

• Conduct and manage the resolution of deviations, root cause investigations, impact assessments, and CAPAs.
• Liaise with multiple groups and organizations to ensure effective collaboration.
• Proactively manage the progression of investigations and CAPAs to achieve timely closure.
• Lead and participate in cross-functional investigation teams.
• Present investigation findings to key stakeholders and site management.
• Apply Quality Risk Management and Operational Excellence principles to enable risk-based decision-making, drive continuous improvement, and eliminate waste.
• Investigate Quality Control deviations, including Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
  
  

Qualifications:

• Required Bachelor's degree in chemical/biochemical engineering, biological sciences, or a related discipline with 2-4 years of relevant experience (or equivalent).
• Prior experience leading cGMP investigations using formal Root Cause Analysis tools required.
• Strong project management skills, including organization, collaboration, multi-tasking, and communication.
• Attention to detail and ability to perform well in a team-based environment.
• Excellent verbal and written communication skills, with the ability to present information clearly and concisely.
• Strong interpersonal and collaboration skills to influence all levels of the organization.
• Familiarity with SOPs, cGMPs, and working within a regulatory environment preferred.
• Knowledge of cell culture, recovery, and/or purification biopharmaceutical manufacturing preferred.
• Contacts: Work collaboratively with all departments and across all organizational levels.
• Decision-Making: Take action, make recommendations, and work with minimal supervision while collaborating with management to resolve challenges.
• Supervision Received: Assignments generally follow defined processes but may require judgment and independent detail definition. Supervisory guidance is provided as needed, with oversight determined by the complexity and impact of the task.
  
  

Pay Rate: $54.35-$57.65/Hour

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

Christian.Quibuyen@eclaro.com

6466952942

Paul Quibuyen | LinkedIn

Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.