Manufacturing Principle Investigator I

American Regent, Inc. • New Albany, OH

19h • Onsite

About The Position

As a member of the Manufacturing department, the Principal Investigator I ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies, and cGMPs. This is a cross-functional position that interacts with Quality Systems, Manufacturing, Materials Management, Maintenance and QC-Microbiology. This position generates investigation summaries for all departments within the facility and may include data compilation and evaluation, impact assessments, root cause analyses, and corrective/preventive actions. The Principal Investigator I also has responsibilities in the data entry, generation and evaluation of process and performance metrics. The Principal Investigator I also has a critical role in maintaining production schedules and meeting Company goals.

Requirements

• Minimum 1 year experience in a professional setting required.
• Must be able to work independently with minimal supervision.
• Intermediate skills in MS Word and MS Excel are required
• Possesses excellent oral and written English communication and comprehension skills.
• Ability to perform basic mathematical calculations.
• Ability to take feedback constructively and function in a team oriented work environment.
• Ability to work overtime as needed.

Nice To Haves

• Bachelor’s degree preferred.
• Work experience in an FDA regulated environment is preferred.
• Experience investigating issues that may occur during cGMP manufacturing of commercial drug product and summarizing any investigations in written format preferred.
• Experience with MS Visio, and MS Access preferred.
• Technical writing and problem solving skills preferred

Responsibilities

• Ensure event and deviation timelines are maintained through inter-department communication.
• Periodically summarize and present on-going process and performance metrics.
• Gown and enter aseptic manufacturing to support investigations.
• Attends all training programs as required by Company SOPs, procedures and policies.
• Perform any other tasks/duties as assigned by management.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 251-500 employees