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Deviation Investigator

Indotronix International Corporation

Tewksbury, MA
Location: Greenville, NC 27834


Duration: 12 months - Contract


Pay Rate: $40.00 - $50.00/ hr w2


Shift: M-F 8-5

Key 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).
Documentation and Reporting:
  • 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).
Compliance and Quality Assurance:
  • 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.
Continuous Improvement:
  • 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.
Qualifications:
  • Regulated Industry, cGMP environment experience, deviation management, or a e.g., Pharmaceuticals, Manufacturing, Engineering, Medical, Law Enforcement, etc.].
  • Strong Attention to details, technical writing, 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.
Preferred Qualifications:
  • Associate or bachelor's degree in a relevant field such as Life Sciences, Engineering, Medial, or Quality Management with 2+ years of related experience.
  • Preferred Experience: Biologics, Aseptic, Filling Isolators, Six Sigma Certification, Electronic documentation systems.
  • Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
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Vacancy posted more than 2 months ago

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