Manager, QC

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

General Summary:

At Thermo Fisher Scientific Inc., our QC Manager role presents an outstanding opportunity to lead a world-class QC Department within our manufacturing site in the United States. You will coordinate QC personnel and testing including environmental monitoring, microbiological identification, sterility, bioburden, endotoxin, and analytical testing for raw materials, semi-finished, and finished goods. Your leadership will guarantee the flawless quality of our products and compliance with global regulations, embodying our 4i values and Quality Policy.

Essential Functions:

• Responsible for timely completion of QC tasks, assisting with workload prioritization, and reviewing records for departmental efficiency and effectiveness.
• Conducts test method validation and transfer, as required. Supports the Stability Program and NPI.
• Performs troubleshooting, provides corrective recommendations for team members, and responds to customer feedback and requests promptly and effectively.
• Develops and evaluates department associates and may assist in the selection of new associates to ensure personnel qualifications meet requirements.
• Assigns appropriate training to all QC Microbiology and Chemical Analytical staff.
• Understands current QC standard operating procedures (SOPs), scientific literature, and existing and new technologies applicable to the QC department. Ensures alignment with industry standards (e.g., USP). Leads needed changes and improvements.
• Runs the safety program within the QC laboratory, ensuring the implementation and adherence to safety requirements.
  
  

General - Physical and Environmental Requirements:

• Able to work safely with materials and equipment.
• Potential exposure to fumes and chemicals such as raw materials, cleaners, etc.
• Various levels of gowning and appropriate PPE are required.
  
  

Essential Knowledge, Skills & Experience:

• A Bachelor's degree in a scientific field, preferably in Life Sciences or equivalent experience.
• Minimum 10 years in Pharmaceutical/Medical Device experience, including supervisory/managerial responsibilities.
• Experience in validation, product transfers, and process improvement projects.
• Solid understanding of all operational aspects of the QC Lab and the Quality Management Systems, including quality control and quality assurance.
  
  

Skills

• Models 4i values, accountability, and operational excellence.
• Ability to work in a matrix environment, applying influence and collaboration.
• Can lead, develop, and manage a diverse team with good judgment, confidence, and integrity.
• Excellent verbal and written communication and organizational skills and a keen ability to multi-task in a detailed environment.
  
  

The job tasks identified below are representative of those required to successfully perform the essential functions of this job. Reasonable accommodations may be made as appropriate to enable individuals with qualified disabilities to perform these essential functions.

Perform physical tasks, operate equipment, communicate effectively; maintain visual ability; work overtime; meet attendance expectations; pay attention to details; work independently; meet deadlines.