Deviation Investigator

Indotronix International Corporation•Greenville, NC

10d

About The Position

The Deviation Investigator identifies and documents deviations from standard operating procedures (SOPs), quality standards, and regulatory guidelines, and conducts investigations to determine their root causes. The role collaborates with cross-functional teams to develop and implement corrective and preventive actions (CAPAs). The position maintains detailed records of deviations, investigations, and CAPAs; prepares and presents reports to management and regulatory authorities as required; and ensures documentation follows Good Documentation Practices (GDP). It also supports compliance with company policies, industry standards, and regulatory requirements, and participates in audits, inspections, trend analysis, and training related to deviation management and quality assurance.

Requirements

Experience in a regulated industry or cGMP environment, or in deviation management; examples include pharmaceuticals, manufacturing, engineering, medical, or 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, or regulatory guidelines.
Conduct thorough 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 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 relevant documentation and information about deviations.
Analyze deviation trends and provide insights for continuous improvement initiatives.
Participate in training programs to enhance knowledge and skills related to deviation management and quality assurance.