Deviation Investigator
Indotronix International Corporation•Greenville, NC
About The Position
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.
Requirements
- 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.
Nice To Haves
- Associate or bachelor’s degree in Life Sciences, Engineering, Medical, or Quality Management.
- Experience with biologics, aseptic operations, or filling isolators.
- Six Sigma Certification.
- Familiarity with electronic documentation systems, GMP, and GLP.
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.
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.
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