Deviation Investigator

Job Summary: Deviation Investigator

About the Role
Join a dynamic team in Greenville, NC as a Deviation Investigator, where your expertise in quality management will directly impact regulated industry standards. This contract opportunity places you at the forefront of compliance and process improvement, engaging with cross-functional teams to ensure the highest standards in pharmaceuticals, biologics, or manufacturing environments. If you are detail-oriented and passionate about continuous improvement, this role offers a pathway for career development and skill enhancement.

Responsibilities

- Identify and document deviations from SOPs, quality standards, or regulatory guidelines
- Conduct thorough root cause investigations for all deviations
- Collaborate with teams to develop and implement corrective and preventive actions (CAPAs)
- Maintain comprehensive and accurate records in line with Good Documentation Practices (GDP)
- Prepare and present deviation reports for management and regulatory bodies
- Ensure strict adherence to company policies, cGMP, and regulatory requirements
- Support and participate in internal and external audits and inspections
- Analyze deviation trends to recommend process improvements
- Participate in ongoing training programs to expand knowledge and expertise

Required Skills and Experience

- 2 5 years experience in a regulated industry (pharmaceuticals, manufacturing, engineering, medical, etc.)
- Hands-on experience in deviation management within cGMP environments
- Strong attention to detail, technical writing, analytical, and problem-solving skills
- Proficient in Microsoft Word, Excel, and PowerPoint
- Knowledge of regulatory requirements and standards
- Excellent communication and interpersonal skills

Preferred Skills

- Associate or bachelor s degree in Life Sciences, Engineering, Medical, or Quality Management
- Experience with biologics, aseptic operations, filling isolators
- Six Sigma Certification
- Familiarity with electronic documentation systems, GMP, and GLP

Benefits

- Collaborative, growth-focused work environment
- Opportunities for professional development and training
- Exposure to advanced quality management and compliance practices
- Direct involvement in process improvement initiatives

How to Apply
Ready to advance your career in quality assurance? Submit your resume and a brief cover letter highlighting your experience in deviation management and quality systems. Join us in shaping industry standards and driving continuous improvement.