Deviation Investigator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

• Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc...

About the Role

We are seeking a Deviation Investigator to analyze and investigate deviations or non-conformances, using problem-solving tools like root cause analysis.

Responsibilities

Manage deviation investigations, including assembling investigation teams, leading root cause analysis, and development of CAPAs.
Document findings in a comprehensive, compliant, and objective manner, ensuring accurate recording of all relevant information.
Collaborate with cross-functional teams, including manufacturing, quality assurance, process engineering, and regulatory affairs, to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs).

Ensure timely completion of investigations.
Clearly communicate investigation progress to impacted areas and leadership.
Participate in client communications and responses, working closely with program team leads, quality, and management.
Continuously improve investigation processes and tools to enhance efficiency and effectiveness.
Escalate issues timely and appropriately.

Requirements

• Education: BS/BA in biology, biochemistry, chemistry, chemical engineering, or other science-related field preferred
• Experience: 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility preferred
• Experience: 5+ years of experience in direct utilization of problem-solving tools (Root Cause Analysis and/or LEAN/six sigma experience) with demonstrated success preferred
• Experience: 3+ years of experience working in biologics preferred
• Experience: Experience using a Quality Management System such as Veeva or Trackwise
• Knowledge: Strong understanding of regulatory requirements (e.g., FDA, EMA, ISO) and Good Manufacturing Practices (GMP)

Qualifications

• Skills: Strong written and verbal communication skills, Ability to evaluate data and make recommendations based on trends and trend analysis, Ability to work effectively in a fast-paced environment and prioritize tasks, Ability to facilitate meetings for desired outcomes, Proven experience with root cause analysis and CAPA processes, Excellent analytical and problem-solving skills, Ability to work independently and manage multiple investigations simultaneously

Benefits

Competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.