Deviation Investigator
About The Position
The Deviation Investigator identifies and documents deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines, then investigates them to determine root causes. The role collaborates with cross-functional teams to develop and implement corrective and preventive actions (CAPAs). The investigator maintains accurate records of deviations, investigations, and CAPAs; prepares and presents reports to management and regulatory authorities as required; and ensures documentation meets Good Documentation Practices (GDP). The role also supports compliance with company policies, industry standards, and regulatory requirements, and participates in audits, inspections, training, and continuous-improvement initiatives. This is a 12-month contract role in Greenville, North Carolina, with a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule. The stated pay rate is $40.00–$50.00 per hour on W-2.
Requirements
- Experience in a regulated industry or cGMP environment, or experience 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 in biologics, aseptic processing, 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, or 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.
- Ensure documentation is completed 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 related to deviation management and quality assurance.
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What This Job Offers
Education Level
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