Deviation Investigator

Devens, Massachusetts
April 8, 2026
$53 / hour
Contract
Apply Now

Apply for this job

Upload CV (doc, docx, pdf)

Job Description

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, Skills, and Abilities:

  • 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.

Related Jobs