Senior Quality Investigation Specialist

Insight Global (United States); Athens (GA); On-site; USD 110,000 - 150,000; Full time

Job summary

Insight Global is seeking a Senior Quality Investigation Specialist to support a GMP pharmaceutical site by reviewing, overseeing, and approving nonconformance and deviation investigations. The role focuses on drafting investigations as needed while ensuring high-quality reviews of root-cause analyses and CAPA effectiveness.

You will challenge root-cause conclusions, guide investigation owners, and drive timely, compliant closures in a 24/7 manufacturing environment.

Qualifications

• 5+ years of pharmaceutical GMP experience with deviation/nonconformance investigations.
• Experience reviewing investigations, not only writing them.
• Strong root-cause analysis and CAPA knowledge.
• Ability to challenge conclusions with objective evidence.
• Excellent GMP technical writing and documentation review.
• Experience working cross-functionally with Manufacturing/QA/QC/Engineering.

Responsibilities

• Review and approve GMP deviations/nonconformance investigations through closure.
• Evaluate investigations for technical accuracy, completeness, and regulatory risk.
• Challenge root-cause determinations and ensure supported conclusions.
• Guide investigation owners through milestones, requirements, and timelines.
• Review technical writing and identify weak or unsupported language.
• Evaluate CAPAs for appropriateness and effectiveness.
• Conduct or support interviews with Manufacturing, QA, QC, Maintenance, and Engineering.
• Coach investigators on root-cause analysis and best practices.
• Identify recurring issues and systemic quality concerns.
• Drive investigations toward timely closure in a fast-paced plant.

Skills

GMP experience

Root cause analysis

Quality writing

Investigation review

Cross-functional collaboration

CAPA evaluation

Deviations and nonconformances

Tools

COMET QMS

Job description

Job Description

We are seeking an experienced Senior Quality Investigation Specialist to support a GMP pharmaceutical manufacturing site with the review, oversight, and approval of nonconformance and deviation investigations.

This is not primarily an investigation-writ ing position. Investigation owners will be responsible for drafting investigations. This individual will serve as the senior Quality reviewer responsible for assessing investigation quality, challenging root-cause conclusions, identifying potential compliance gaps, guiding investigation owners, and driving investigations toward timely and compliant closure.

The ideal candidate has significant experience within GMP pharmaceutical manufacturing and is comfortable independently reviewing complex investigations involving manufacturing processes, laboratory testing, materials, equipment, documentation, human performance, and other quality events.

Responsibilities

• Review and approve GMP deviations and nonconformance investigations through closure
• Evaluate investigations for technical accuracy, completeness, and regulatory/compliance risk
• Challenge root-cause determinations and ensure conclusions are supported by objective evidence
• Guide investigation owners through investigation milestones, requirements, and timelines
• Review technical writing and identify weak or unsupported investigation language
• Evaluate proposed corrective and preventive actions (CAPAs) for appropriateness and effectiveness
• Conduct and/or support interviews with Manufacturing, Quality Control, Maintenance, Engineering, and other stakeholders
• Coach investigation owners on root-cause analysis and investigation best practices
• Identify recurring issues, investigation risks, and potential systemic quality concerns
• Drive investigations toward compliant and timely closure in a fast-paced manufacturing environment

Skills and Requirements

• 5+ years of pharmaceutical/biopharmaceutical GMP experience, ideally with significant deviation/nonconformance investigation responsibility
• Hands-on experience with deviations, nonconformances, and GMP investigations
• Demonstrated experience reviewing and/or approving investigations, not solely writing them
• Strong knowledge of root-cause analysis and CAPA principles
• Ability to critically evaluate investigation conclusions and identify unsupported assumptions, weak root-cause logic, or potential compliance risk
• Strong GMP technical writing and document-review skills
• Comfortable challenging, questioning, and coaching investigation owners and cross-functional SMEs
• Experience working cross-functionally with areas such as Manufacturing/Operations, QA, QC, Engineering, or Maintenance
• Ability to independently manage multiple investigations and drive them toward closure
• Strong communication and stakeholder-management skills
• API or small-molecule pharmaceutical manufacturing experience
• Experience supporting investigations in a 24/7 manufacturing environment
• QC/laboratory investigation experience, including testing failures or unexpected results
• Experience with raw-material, bulk-solvent, supplier, or material-related investigations
• Experience reviewing data-integrity or documentation-related events
• Experience with microbial, environmental, or water-system investigations
• COMET or similar electronic quality management system experience
• Previous experience working in a senior QA, Quality Engineering, Manufacturing Quality, QC, or dedicated Investigations function
• Local to Athens, GA or within reasonable commuting distance

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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 the recruiting process, please send a request to [e-mail].