Manager, QC

Job Description

Job Description:

When you join the team at Thermo Fisher Scientific, you become part of a company that is dedicated to making a positive impact on the world. We are passionate about finding cures for cancer, protecting the environment, and ensuring the safety of our food. Your work as a Quality Control Manager will have a real-world impact, and you will be supported in achieving your career goals. We value intensity, integrity, innovation, and involvement and strive to bring together extraordinary colleagues who share our values.

Thermo Fisher Scientific is a company of 100,000 extraordinary minds, each with a unique story to tell. Join us and support our mission of making the world healthier, cleaner, and safer.

• Lead all aspects of the full Quality Control of materials through batch record review and release.
• Assist in prioritizing workload and assigning testing to ensure the effective daily operation of the department.
• Review data reports, document results, and complete all required documentation and electronic system entries.
• Ensure accurate and timely completion of testing activities and projects.
• Perform test method validation and transfer as required.
• Assist in writing and revising documentation, including test methods, product specifications, SOPs, etc.
• Analyze and implement improvements related to QC processes and procedures.
• Troubleshoot and provide corrective recommendations for team members or customer feedback purposes.
• Develop and evaluate department associates and assist in the selection of new associates to ensure efficient operation.
• Provide supervision to Quality Control associates, schedule tasks, and monitor task completion.
• Communicate with other departments and external customers within the area of responsibility.
• Maintain working knowledge of current QC standard operating procedures (SOPs), scientific literature, and new technologies within the scientific field.
• Provide training to other staff members.
• Ensure timely, accurate, qualified, and cost-effective testing is performed on raw materials, in-process materials, finished goods, and procured finished goods.
• Lead and ensure compliance with assigned Quality systems, including Quality Control System, Quality Inspections, and Stability Program.
• Perform all job duties within regulatory or statutory requirements.

• Bachelor's degree in Life Sciences or Engineering required.

• Minimum 10 years of experience in the Pharmaceutical/Medical Device industry, including progressive supervisory/managerial experience preferred.
• Experience in facilities/utilities, product transfers, and site expansion projects.
• Solid understanding of Lab testing and Quality Management Systems, including quality control.
• Familiarity with quality system regulations/requirements (ISO 13485, 21 CFR Part 820)
• Ability to write and understand technically related protocols.

• Ability to work in a matrix environment and use influence to achieve the desired results
• Strong written and verbal communication skills, with the ability to relate across all levels of the organization.
• Strong analytical thinking and problem-solving skills.
• Ability to lead teams, self-motivated, and able to prioritize activities with minimal direction.
• Exercise judgment within defined practices and policies when selecting methods and techniques for obtaining solutions.
• Proficiency in Microsoft Office and statistical programs (Minitab, SAS).
• Strong application of technical principles, practices, and procedures.
• Ability to multitask and manage conflict effectively.