Sr Manager, QC

at  Thermo Fisher Scientific

JOB DESCRIPTION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our distributed team of more than 130,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands.

SUMMARY:

This is an exciting time to join the Florence team. In this role you will assure compliance and quality are defined, implemented, practiced, maintained, and matured. This position is a leadership position leading, developing/mentoring, and being responsible for the Quality Control Department for an AP and Food manufacturing site that is responsible for the execution of tests that are required by the customer for intermediates and final materials as well as the routine testing for raw materials, facilities, utilities, and manufacturing systems as applicable.

Essential Functions:

• Direct laboratory operations in an organized and efficient manner to prevent any delays in product release. Runs the activities of the QC lab to assure that all test samples meet the in-process, raw materials, intermediate, final product, and stability specifications.
• Review and approve SOPs, validation protocols, investigations, batch records, analytical methods, specifications as they relate to this department.
• Work with the lab Managers and Supervisors to author Deviations, Change Controls, CAPAs, OOS/OOT investigations.
• Responsible for compliance of the QC laboratory and personnel.
• Participate in internal, client and regulatory audits.
• Interact with other departments as required to define and/or verify the scope of work for a particular project; e.g., Provide testing services for validation work.
• Responsible for the scientific and managerial training for the staff to assure a competent, professional, and committed work force.
• Ensure the completion of projects within budget limits and time projections.

Qualifications:

• Technical/Professional Knowledge - having achieved a satisfactory level of technical and professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise.
• Delegation -the individual delegates work assignments, gives authority to work independently, sets expectations and monitors delegated activities.
• Leadership -the individual inspires and motivates others to perform well and accepts feedback from others.
• Safety and Security -the individual observes safety and security procedures and uses equipment and materials properly. May be required to lift items that are approximately 25lbs.
• Management Skills -the individual includes staff in planning, decision-making, facilitating and process improvement; makes self available to staff; provides regular performance feedback; and develops subordinates’ skills and encourages growth.
• Decision Making - identifying and understanding issues, problems and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
• Stress Tolerance - maintaining stable performance under pressure or opposition.

EDUCATION:

Minimum of a B.S. in Chemistry or related field.

• Direct laboratory operations in an organized and efficient manner to prevent any delays in product release. Runs the activities of the QC lab to assure that all test samples meet the in-process, raw materials, intermediate, final product, and stability specifications.
• Review and approve SOPs, validation protocols, investigations, batch records, analytical methods, specifications as they relate to this department.
• Work with the lab Managers and Supervisors to author Deviations, Change Controls, CAPAs, OOS/OOT investigations.
• Responsible for compliance of the QC laboratory and personnel.
• Participate in internal, client and regulatory audits.
• Interact with other departments as required to define and/or verify the scope of work for a particular project; e.g., Provide testing services for validation work.
• Responsible for the scientific and managerial training for the staff to assure a competent, professional, and committed work force.
• Ensure the completion of projects within budget limits and time projections