Deviation Investigator

Indotronix International Corporation • Greenville, NC

10d

About The Position

Join a team in regulated-industry compliance as a Deviation Investigator in a cGMP manufacturing environment. The role investigates deviations and supports regulatory and process standards. It is a contract position based in Greenville, NC, with exposure to cross-functional teams and opportunities to contribute to continuous improvement initiatives.

The investigator identifies and documents deviations, conducts root cause investigations, supports corrective and preventive actions (CAPAs), and maintains records in accordance with Good Documentation Practices. The role also supports audits and inspections, prepares reports, analyzes trends, and participates in ongoing training related to deviation management and quality assurance.

Requirements

• 2–5 years of experience in a regulated, cGMP environment, such as pharmaceuticals, manufacturing, engineering, medical, or law enforcement.
• Strong attention to detail, technical writing, analytical, and problem-solving abilities.
• Solid understanding of regulatory requirements and quality standards.
• Proficiency in Microsoft Suite, including Word, Excel, and PowerPoint.
• Excellent communication and interpersonal skills.

Nice To Haves

• Associate or Bachelor’s degree in Life Sciences, Engineering, Medical, or Quality Management.
• Experience with biologics, aseptic processing, or filling isolators.
• Familiarity with electronic documentation systems.
• Six Sigma certification.
• Knowledge of GMP and GLP.

Responsibilities

• Identify, document, and track deviations from SOPs, quality standards, or regulatory guidelines.
• Conduct root cause investigations to determine the source of deviations.
• Collaborate with internal teams to develop and implement corrective and preventive actions (CAPAs).
• Maintain records of deviations, investigations, and CAPAs in accordance with Good Documentation Practices (GDP).
• Prepare and present deviation reports to management and regulatory bodies as required.
• Participate in audits and inspections, providing documentation and insights as needed.
• Analyze deviation trends and recommend improvements to processes and quality systems.
• Engage in ongoing training to enhance skills in deviation management and quality assurance.

Benefits

• Professional development through hands-on experience and training.
• Exposure to advanced quality management systems and regulatory frameworks.
• Collaborative work culture with opportunities for networking and career advancement.

What This Job Offers

• Education Level: No Education Listed