Deviation Investigator

Job Title: Deviation Investigator
Job Location: Devens, MA (50% onsite required)
Job Duration: 6 Months (possibility of extension)
Work Schedule: Mon- Fri(normal business hours)
Payrate: $53.21/ hr. on w2

Major Duties and 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.

Knowledge and Skills:

• 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.

Working Conditions:

• Assignments primarily occur in the Large-Scale Cell Culture building, Single-Use Facility, and Quality Control Laboratory areas, requiring strict adherence to Personal Protective Equipment (PPE) standards.
• Site is located in Devens, Massachusetts.

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.