Catalent, Inc
Site Deviation Investigator
Greendale, IN
Sponsorship not specifiedDetected 2 days ago
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About the role
- We have an opportunity for a Site Deviation Investigator to join our team.
- In this role, you will be responsible for leading investigations into deviations that occur during the manufacturing process, including packaging, processing, and supporting areas.
- Gather information from internal and external sources to evaluate deviation impact on products and future operations.
Responsibilities
- You will identify root causes, implement corrective and preventive actions, and monitor trends to prevent recurrence.
- This position requires working independently, collaborating with cross-functional teams, and ensuring compliance with Good Manufacturing Practices to maintain readiness for regulatory inspections.
- Work independently to comply with procedure-driven guidelines for deviation investigations and maintain deadlines.
- Drive continuous improvement in manufacturing operations.
- Assess historical manufacturing and laboratory data, apply root-cause analysis tools, and design corrective and preventive actions to address quality deficiencies.
- Lead revision or development of Standard Operating Procedures as defined in corrective and preventive actions.
Requirements
- Three to five years of experience in manufacturing or related work with emphasis on current Good Manufacturing Practices, including Quality Assurance, Quality Control, Validation, Manufacturing, or process engineering.
- Proven ability to influence others outside your department.
- Knowledge of governing standards and regulations (e.g., 21 CFR Part 4, Part 11, Parts 210/211, Part 820 QSR, ISO 13485, ISO 14971, JPAL).
- Basic knowledge of statistical tools and their application.
- Ability to work effectively under pressure to meet deadlines.
- Experience working with third-party contract manufacturing in the industry.
- Individual may be required to sit and stand for extended periods.
- Ability to enter manufacturing areas requiring full gowning, including bending, kneeling, and standing for long periods in cleanroom or warehouse areas.
Nice to have
- Preferred Skills & Background
- Previous experience in processing or batching manufacturing is preferred.
Compensation
- Defined career path with annual performance reviews and growth opportunities.
Benefits
- Catalent's Greendale, Indiana site is a key part of the company's Wellness business, serving as one of North America's primary gummy development and manufacturing centers.
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