Thermo Fisher Scientific Sr Quality Specialist in Allentown, Pennsylvania
• Apply Good manufacturing Principles in all areas of responsibility.
• Demonstrate and promotes the company vision.
• Maintaining current equipment and facilities qualification documentation.
• Perform impact analysis of changes to facilities and equipment.
• Review and Approve equipment and facilities qualification documents to ensure compliance with all applicable internal and regulatory standards.
• Informs management of issues identified during qualification activities and recommends appropriate actions to address the issue(s).
• Drives continuous improvement to the site’s equipment and facilities qualification/validation program.
• Assist in the authoring of site procedures related to equipment and facilities as required
• Monitor the site’s calibration program.
• Monitor the site’s preventative maintenance program.
• Author qualification documents as required.
• Conduct all activities in a safe and efficient manner.
• Other duties may be assigned to meet business/compliance needs.
• Minimum Qualifications:
• Bachelors Degree.
• A minimum of 5 years in the pharmaceutical/related regulated industry.
• Experience with equipment and facilities validation Quality Systems.
• Must be detail oriented to detect errors or deficiencies with equipment and facilities qualification documentation.
• Possess the ability to use sound judgment in discerning if equipment and facilities qualification documentation accurately and completely reflects the documentation and requirements of the system.
• Utmost integrity and personal responsibility are required to maintain the highest ethical standards for regulatory compliance.
• Good written and verbal communication skills.
• Thorough understanding of regulatory documentation requirements.
• Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
• Ability to work independently.
• Experience in Microsoft Word, Excel, and Power Point.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.