Job Description

Specific Job Requirements

• Technical writing skills
• Critical thinking skills and detail oriented
• Creation of general business documents and procedures
• Understanding of applicable governmental regulations
• Participates in internal and external audits, travel may apply
• Communicates issues to Quality Management
• Ability to collaborate as a member of cross-functional teams
• Support regulatory inspections
• Support media fills
• Additional tasks as required

Performs/reviews the following as applicable by functional unit:

• Deviations
• Complaints
• Discrepant Material reports
• Laboratory Out of Limits
• Building Monitoring System Out of Limits
• Calibration Out of Tolerance
• Product Out of Yield
• Corrective/Preventative Action reports
• Critical System Work Orders
• Change Notifications
• Change Requests
• Document revisions
• Protocols
• Compilation of metrics

Education Requirements

· Bachelor’s degree in a scientific field

Work Experience Requirements

· 2-5 years of pharmaceutical manufacturing experience (or post-secondary education) is required

Physical Demands

The physical demands described here are representative of those that could be required of an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Requires Type 4 Garb qualification (Sterile Containment Suit, Sterile Hood, Sterile Face Mask, Sterile Gloves, Sterile Boots, and Sterile Goggles).
• While performing the duties of this job, the employee is frequently required to sit, talk, and hear.
• Specific vision abilities required by this job include close vision and ability to adjust focus.
• Must be able to pass visual acuity test

Computer Skills

To perform this job successfully, an individual should have basic computer knowledge such as Word Processing and Database software as well as Edwards or equivalent inventory softwar

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