Deviation Investigator

Job Title: Deviation Investigator
Location: Devens, MA
Contractor Work Model: Hybrid – 50% on-site / 50% remote
Hours: M-F Normal Business Hours
Compensation: $50.00 - $53.20/hr
Type: Contract, Potential for extension or conversion to permanent

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.
  

• 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.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M-