Deviation Investigator
About The Position
The Deviation Investigator identifies and documents deviations from standard operating procedures (SOPs), quality standards, and regulatory guidelines; investigates deviations to determine root causes; and collaborates with cross-functional teams to develop and implement corrective and preventive actions (CAPAs). The role maintains detailed records, prepares reports, and ensures documentation follows Good Documentation Practices (GDP). It also supports compliance with company policies and applicable industry and regulatory requirements, participates in audits and inspections, and contributes to continuous improvement through trend analysis and training. The position is fully onsite, Monday through Friday, 8 a.m. to 5 p.m.
Requirements
- Experience in a regulated industry or cGMP environment, or in deviation management; examples listed include pharmaceuticals, manufacturing, engineering, medical, and law enforcement.
- Strong attention to detail.
- Technical writing skills.
- Analytical and problem-solving skills.
- Knowledge of regulatory requirements and standards.
- Intermediate to advanced skills in Microsoft Word, Excel, and PowerPoint.
- Excellent communication and interpersonal skills.
Nice To Haves
- Associate or bachelor's degree in a relevant field such as Life Sciences, Engineering, Medical, or Quality Management, with 2+ years of related experience.
- Experience with biologics, aseptic processes, or filling isolators.
- Six Sigma certification.
- Experience with electronic documentation systems.
- Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Responsibilities
- Identify and document deviations from SOPs, quality standards, and regulatory guidelines.
- Conduct investigations to determine the root cause of deviations.
- Collaborate with cross-functional teams to develop and implement CAPAs.
- Maintain accurate and detailed records of deviations, investigations, and CAPAs.
- Prepare and present deviation reports to management and regulatory authorities as required.
- Complete documentation in accordance with Good Documentation Practices (GDP).
- Ensure deviations are managed in compliance with company policies, industry standards, and regulatory requirements.
- Participate in internal and external audits and inspections, providing documentation and information related to deviations.
- Analyze deviation trends and provide insights for continuous improvement initiatives.
- Participate in training programs to strengthen knowledge and skills in deviation management and quality assurance.
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What This Job Offers
Job Type
Full-time
Education Level
No Education Listed
