Manufacturing Compliance Investigator Contractor

The Technical Investigator is responsible for initiating, investigating, and completing process deviations, Change Controls, and CAPAs for the assigned department. The role identifies root causes, assesses product quality impact, and implements corrective actions to prevent recurrence. The investigator also drafts and manages departmental Change Controls.

Essential Duties & Responsibilities:

• Translate moderate to complex scientific events into brief, cohesive investigation reports for an educated reader. Document immediate actions and containment, and address internal and external comments on final reports.
• Gather data from site sources; perform root cause analysis, trending analysis, risk assessments, cause mapping, and interviews; assess impact to product safety, identity, strength, quality, and purity; identify corrective and preventive actions.
• Manage multiple projects and timelines concurrently, adhere to standard timelines, and escalate actions for timely resolution.
• Work with relevant departments to gather data, observe processes, and interview associates during investigations.
• Facilitate meetings with internal teams and subject matter experts to agree on an investigation path, resolve conflicts, solve problems, and keep meetings focused.
• Lead and track Change Controls through completion.
• Maintain quality systems and cGMP compliance by ensuring team members follow applicable processes, procedures, and instructions.
• Know and comply with safety policies, rules, and regulations, and ensure team members comply.
• Perform other duties as assigned.

Minimum Qualifications:

• Education/Training:
  • Undergraduate degree in a science discipline.
• Experience:
  • At least 3-5 years of experience in cell therapy, biotechnology, or pharmaceutical cGMP environment, including experience investigating deviations and writing investigation reports. Experience with root cause analysis, CAPAs, and Change Controls is required.

• Knowledge: Working knowledge of cGMP quality systems, SOPs, batch records, and regulatory requirements applicable to manufacturing. Ability to assess potential product quality impact.
• Skills: Strong technical writing, organization, recordkeeping, and communication skills. Ability to interview employees, work across departments, manage multiple investigations and deadlines, and use Microsoft Word, Excel, and PowerPoint. Ability to work overtime when needed.
• Certifications/Licenses: None required.