Title: Deviation Investigator
Location: Greenville, NC 27834 (Full onsite)
Duration: 12 months
Shift time: Shift: Monday-Friday 8-5
Description: 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).