QA CAPA Investigations Specialist

About the role

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a QA CAPA Investigation Specialist to support quality investigation and corrective action activities within a regulated manufacturing environment. The successful candidate will be responsible for conducting and documenting investigations, supporting Corrective and Preventive Action activities, performing root cause analysis, and collaborating with cross-functional teams to ensure quality issues are thoroughly evaluated, appropriately documented, and effectively resolved.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team. Excited to build something meaningful together? We look forward to hearing from you.

Responsibilities

• Conduct and document quality investigations, CAPAs, nonconformances, and related quality events.
• Gather and analyze relevant data, records, and supporting documentation.
• Perform structured root cause analysis using tools such as 5 Whys, Fishbone/Ishikawa, and other problem-solving methodologies.
• Identify root causes, contributing factors, and potential systemic issues.
• Prepare clear, accurate, and technically sound investigation reports.
• Support the development and implementation of corrective and preventive actions.
• Track assigned CAPA and investigation activities through completion.
• Support effectiveness checks to verify that implemented actions achieved the intended results.
• Collaborate with cross-functional stakeholders to obtain information, resolve open items, and complete investigations within established timelines.
• Review supporting documentation to ensure conclusions are based on objective evidence and appropriate technical rationale.
• Assist with trend analysis and identification of recurring quality issues.
• Support audit and regulatory inspection readiness activities as needed.
• Maintain complete and timely documentation in accordance with applicable procedures and regulatory requirements.

Requirements

• Bachelor’s degree in Engineering, Science, Quality, Manufacturing, or a related technical discipline.
• Typically 3–5 years of experience in Quality Assurance, Quality Compliance, Investigations, CAPA, or a related function within an FDA-regulated industry.
• Hands-on experience conducting or supporting CAPAs, deviations, nonconformances, or quality investigations.
• Working knowledge of structured root cause analysis and problem-solving methodologies.
• Strong technical writing and documentation skills.
• Strong analytical and organizational skills.
• Ability to manage multiple investigations and priorities simultaneously.
• Effective written and verbal communication skills.
• Ability to work collaboratively with cross-functional teams.

Qualifications

• Experience in medical device, pharmaceutical, or other regulated manufacturing environments.
• Familiarity with applicable FDA regulations and GMP requirements.
• Experience with risk assessment tools such as FMEA.
• Experience using electronic Quality Management Systems.
• Lean Six Sigma or Quality-related training is a plus.