Site Deviation Investigator

Catalent Pharma Solutions • Greendale, IN

6d • Onsite

About The Position

Site Deviation Investigator Position Summary Work Schedule: Monday to Friday, business hours 100% on-site in Greendale, IN Greendale is one of Catalent’s gummy technology development and manufacturing facilities in North America. The site manufactures organic and vegan-based nutraceuticals via confection to enhance wellness for all consumers. The Site Deviation Investigator will be independently responsible for the efficient and thorough investigation of deviations that occur during manufacturing process (Packaging, Processing Kitchen and Mogul, including manufacturing supporting areas). The incumbent will lead the determination of deviation root cause and the initiation of corrective/preventative actions designed to adequately correct the Quality/Process related deficiencies identified during the investigation process. The Site Deviation Investigator is also responsible for monitoring events and trends in order to provide proactive corrections/ improvements alternatives to minimize the potential for repeat incidents. The Role Gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured products, as well as the risk to future operations. Liaison with inter-departmental teams to drive data gathering that supports the timely investigation completion. Properly assess manufacturing and laboratory analytical historical data, apply methodical root-cause analysis tools, documents comprehensive root cause analysis and design adequate corrective/preventative actions to eliminate Quality deficiencies identified through the investigative process. Provide technical expertise to the site on thorough and complete deviation investigations process. Works independently to comply with procedure driven guidelines relating to Deviation investigations. Ensures that deadlines are maintained and monitors the need for extensions in order to maintain investigation process in compliance. Lead revision or development of Standard Operating Procedures as defined in CAPAs. Drive continuous improvement in manufacturing operations. Utilize appropriate risk management tools to ensure proper determination of product quality in order to support material/product disposition. Other duties assigned

Requirements

• Bachelors Degree required
• 3+ years of experience in manufacturing or related work experience with emphasis on current Good Manufacturing Practices including: QA, QC, Validation, Manufacturing, or process engineering required
• Ability to articulate, discuss and summarize technical information from Manufacturing, QC, QA, RA and engineering areas to compose complete and comprehensive investigation reports.
• Basic knowledge in statistics tools and its application.
• Experience working with third-party contract manufacturing in industry
• Proficient skills in Microsoft Office applications
• Knowledge of governing standards and regulations (e.g., 21CFR Part 4, Part 11, Parts 210/211, Part 820 QSR, ISO 13485, ISO 14971, JPAL
• Advanced technical writing skills are highly desired
• Able to interface positively with Regulatory Agencies, customers and company departments.
• Previous experience in processing/batching manufacturing is preferred.
• Conducting investigations and putting verbiage together to explain why/how it happened
• Individual may be required to sit and stand for an extended period of time
• Ability to enter manufacturing areas requiring full gowning (e.g., ability to bend, kneel, and stand on feet for long periods of time in a clean room or warehouse area).
• Frequent sitting, standing, walking, reading of written documents and using computer monitor screen, reaching with hands and arms, talking, writing, listening.
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 35 pounds.

Nice To Haves

• Previous experience in processing/batching manufacturing is preferred.
• Conducting investigations and putting verbiage together to explain why/how it happened

Responsibilities

• Gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured products, as well as the risk to future operations.
• Liaison with inter-departmental teams to drive data gathering that supports the timely investigation completion.
• Properly assess manufacturing and laboratory analytical historical data, apply methodical root-cause analysis tools, documents comprehensive root cause analysis and design adequate corrective/preventative actions to eliminate Quality deficiencies identified through the investigative process.
• Provide technical expertise to the site on thorough and complete deviation investigations process.
• Works independently to comply with procedure driven guidelines relating to Deviation investigations.
• Ensures that deadlines are maintained and monitors the need for extensions in order to maintain investigation process in compliance.
• Lead revision or development of Standard Operating Procedures as defined in CAPAs.
• Drive continuous improvement in manufacturing operations.
• Utilize appropriate risk management tools to ensure proper determination of product quality in order to support material/product disposition.
• Other duties assigned

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 152 hours of paid time off + 8 paid holidays
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive salary with quarterly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees