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Global Product Development and Supply - Deviation Investigator

ECLARO

Devens, MA

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JOB DETAILS
SALARY
$54.35–$57.65 Per Hour
SKILLS
Biochemistry, Biology, Cell Cultures, Chemical Engineering, Communication Skills, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Dental Insurance, Detail Oriented, Diversity, Genetics, Healthcare, Interpersonal Skills, Leadership, Manufacturing, Medical Products, Multitasking, Presentation/Verbal Skills, Process Improvement, Product Development, Project/Program Management, Quality Control, Quality Management, Regulations, Regulatory Compliance, Risk, Risk Management, Root Cause Analysis, Standard Operating Procedures (SOP), Team Player, Time Management, Vision Plan, Writing Skills
LOCATION
Devens, MA
POSTED
11 days ago
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.
 

About the Company

E

ECLARO

Eclaro is a Business and Technology Consulting Firm that connects top talent with opportunities nationwide. We have direct access to Hiring Managers from leading Fortune 1000 organizations in almost every industry segment, with particular expertise in:

• Technology and Business Consulting
• Financial Services and Insurance
• Pharmaceuticals and Life Sciences
• Consumer Products, Public Sector, and Utilities

Eclaro provides fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including:

• Consulting
• Professional Hiring
• Global Integrated Delivery™
• Managed Services

Eclaro recruits and manages a staff of highly skilled individuals in an array of specialized disciplines enabling our clients to leverage new opportunities, respond to increased and changing demands, and increase their profitability.

Eclaro’s Management Team averages over 25 years of experience in partnering with clients in technical, corporate operations and human capital solutions. We hold ISO 9001:2008 certification and have achieved SOC 2 Type 2 certification in Security, Availability and Confidentiality. Eclaro’s decades of expertise and collaborative practice have proven that The Right People are The Answer.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1999
WEBSITE
http://www.eclaroit.com

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