OOS Writer

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

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:

Required Skills & Experience

Qualifications
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

Skills

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

Benefit packages for this role will start on the 1st 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.