OOS Writer
Insight Global, Raleigh, NC, United States
Job Description
We’re seeking an experienced Investigator – Exceptions / OOS Writer to support Quality operations in a regulated pharmaceutical manufacturing environment. This role is responsible for leading and authoring deviation, exception, and OOS investigations, ensuring timely, thorough, and compliant documentation in accordance with cGMP and regulatory expectations. The ideal candidate is detail-oriented, analytical, and comfortable working cross-functionally in a fast‑paced quality organization.
Location & Schedule Raleigh, NC (on‑site)
Shift and overtime requirements may vary based on production and investigation needs.
Key Responsibilities
Lead and author deviations, exceptions, OOS, and OOT investigations from initiation through closure.
Perform root cause analysis and define effective CAPAs.
Ensure investigations are thorough, scientifically sound, and inspection‑ready.
Collaborate with QC, Manufacturing, Engineering, and Quality teams to gather data and drive resolution.
Review and assess impact to product quality, regulatory compliance, and patient safety.
Support audit readiness and respond to internal and external audit inquiries.
Identify trends and support continuous improvement initiatives.
Maintain accurate, timely documentation in quality systems.
Skills and Requirements
Education: Bachelor’s degree in Chemistry, Biology, Engineering, or related scientific discipline.
Experience: 3+ years of experience in deviation/OOS investigations in an FDA-regulated pharmaceutical manufacturing environment; hands‑on experience authoring investigations and CAPAs required.
Strong knowledge of cGMPs, FDA regulations, and quality systems.
Proven root cause analysis and technical writing skills.
Ability to manage multiple investigations with competing priorities.
Strong attention to detail and critical thinking capabilities.
Effective written and verbal communication skills.
EEO Statement 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/.
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Location & Schedule Raleigh, NC (on‑site)
Shift and overtime requirements may vary based on production and investigation needs.
Key Responsibilities
Lead and author deviations, exceptions, OOS, and OOT investigations from initiation through closure.
Perform root cause analysis and define effective CAPAs.
Ensure investigations are thorough, scientifically sound, and inspection‑ready.
Collaborate with QC, Manufacturing, Engineering, and Quality teams to gather data and drive resolution.
Review and assess impact to product quality, regulatory compliance, and patient safety.
Support audit readiness and respond to internal and external audit inquiries.
Identify trends and support continuous improvement initiatives.
Maintain accurate, timely documentation in quality systems.
Skills and Requirements
Education: Bachelor’s degree in Chemistry, Biology, Engineering, or related scientific discipline.
Experience: 3+ years of experience in deviation/OOS investigations in an FDA-regulated pharmaceutical manufacturing environment; hands‑on experience authoring investigations and CAPAs required.
Strong knowledge of cGMPs, FDA regulations, and quality systems.
Proven root cause analysis and technical writing skills.
Ability to manage multiple investigations with competing priorities.
Strong attention to detail and critical thinking capabilities.
Effective written and verbal communication skills.
EEO Statement 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/.
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