Job Description
Key Responsibilities:
• Lead and document deviations, investigations, and CAPAs within GMP-regulated environments.
• Act as the primary Quality representative for CMRs (Change Management Requests) and TrackWise investigations.
• Provide technical writing support for detailed investigations and root cause analyses (e.g., 5 Whys, Fishbone diagrams).
• Collaborate with operations to assess GMP issues and determine appropriate quality actions.
• Challenge existing processes and contribute to continuous improvement initiatives (e.g., 5S).
• Maintain and review GMP documentation related to instrumentation, equipment, and utilities.
• Support CMMS-related quality activities and ensure compliance with internal procedures.
• Help reduce the burden on managers by owning deviation workflows and TrackWise entries.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
• 3–5 years of experience in a GMP-regulated pharmaceutical or biotech environment.
• Strong working knowledge of GMP principles, documentation practices, and compliance standards.
• Experience with TrackWise or similar deviation/compliance management systems.
• Proven ability to write clear, concise, and technically sound investigations.
• Familiarity with CMMS systems and equipment/instrumentation documentation.
• Ability to work independently and partner effectively with cross-functional teams.
• Strong attention to detail and organizational skills.
Nice to Have Skills & Experience
Experience supporting technical departments such as maintenance, utilities, or instrumentation.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.