Deviation Investigator

Indotronix International Corporation•Tewksbury, MA

1d•Onsite

About The Position

The Deviation Investigator will be responsible for identifying and documenting deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines. This role involves conducting thorough investigations to determine the root cause of deviations and collaborating with cross-functional teams to develop and implement corrective and preventive actions (CAPAs). The investigator will maintain accurate records, prepare reports, and ensure compliance with all relevant regulations and company policies. Additionally, the role contributes to continuous improvement initiatives by analyzing deviation trends and participating in relevant training programs.

Requirements

Regulated Industry, cGMP environment experience
Deviation management experience
Experience in Pharmaceuticals, Manufacturing, Engineering, Medical, or Law Enforcement
Strong Attention to details
Technical writing skills
Analytical and problem-solving skills
Knowledge of regulatory requirements and standards
Intermediate to Advanced skills in Microsoft Suite (Word, Excel, 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
2+ years of related experience
Biologics experience
Aseptic experience
Experience with Filling Isolators
Six Sigma Certification
Experience with Electronic documentation systems
Familiarity with Good Manufacturing Practices (GMP)
Familiarity with Good Laboratory Practices (GLP)

Responsibilities

Identify and document deviations from standard operating procedures (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 all 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 all deviations are managed in compliance with company policies, industry standards, and regulatory requirements.
Participate in internal and external audits and inspections, providing necessary documentation and information related to 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.