Job Description

Poaition:Deviation Investigator
Location: Devens, MA
Duration: 6 Months
50% onsite required
Work Schedule: Mon- Fri(normal business hours)

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

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.

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