Deviation Investigator

VARITE • Greenville, NC

1d • Onsite

About The Position

VARITE is seeking a Deviation Investigator for an onsite, 12-month contract in Greenville, North Carolina, with a possible extension. The role involves identifying and documenting deviations from standard operating procedures, quality standards, and regulatory guidelines; investigating their root causes; and partnering with cross-functional teams to develop and implement corrective and preventive actions (CAPAs). The investigator maintains accurate records, prepares reports, supports audits and inspections, and contributes to continuous improvement in deviation management and quality assurance.

Requirements

• Experience in a regulated industry or cGMP environment, such as pharmaceuticals, manufacturing, engineering, medical, or law enforcement.
• Experience with deviation management.
• 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 standard operating procedures (SOPs), quality standards, or regulatory guidelines.
• Conduct investigations to determine the root cause of deviations.
• Collaborate with cross-functional teams to develop and implement corrective and preventive actions (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 follows Good Documentation Practices (GDP).
• Manage deviations in compliance with company policies, industry standards, and regulatory requirements.
• Participate in internal and external audits and inspections, providing relevant documentation and information.
• Analyze deviation trends and provide insights for continuous improvement initiatives.
• Participate in training programs related to deviation management and quality assurance.

Benefits

• Medical, dental, and vision coverage for eligible employees.
• Participation in a company-sponsored retirement savings plan for eligible employees.
• Legal service plans providing access to attorneys for advice and representation.
• Potential eligibility for an employee referral bonus if a referred candidate is hired.

What This Job Offers

• Education Level: No Education Listed