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.
Description:
- 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.
Qualifications:
- Bachelors degree in Engineering, Science, Quality, Manufacturing, or a related technical discipline.
- Typically 35 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.
- Preferred 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.
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.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
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