The posting
Work Schedule
Standard Office Hours (40/wk)
Environmental Conditions
Laboratory Setting
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
The QC Supervisor leads a Quality Control team supporting pharmaceutical manufacturing, ensuring that laboratory activities meet cGMP standards, regulatory requirements, and customer expectations. The role provides technical and operational leadership across testing activities, from raw materials to finished products, while managing the complexity of multiple analytical methods, customer requirements, and challenging priorities and timelines.
The successful candidate will combine strong analytical and problem-solving skills with the leadership needed to develop the team, support business objectives, and maintain high standards of quality, compliance, and service.
REQUIREMENTS:
- Lead, coach, and develop the QC team, setting clear expectations and aligning day-to-day activities with site and company objectives.
- Plan and coordinate laboratory operations, balancing workload, resources, testing requirements, customer priorities, and turnaround times.
- Provide technical oversight for analytical testing and troubleshooting involving methods and instrumentation such as HPLC, GC testing.
- Proactively identify risks, bottlenecks, and emerging issues that could affect quality, compliance, customer commitments, or timelines; lead appropriate problem-solving and escalation.
- Participate actively in customer calls, communicate laboratory performance and technical matters clearly, and help resolve customer concerns.
- Support and participate in customer audits and regulatory inspections, including preparation, responses, and follow-up actions.
- Take an active role in laboratory investigations, including assessment of results, root cause analysis, definition of corrective and preventive actions, and follow-through to closure.
- Review and interpret operational, quality, and service metrics and KPIs; use trends to anticipate issues, set priorities, and drive timely improvements.
- Ensure accurate, complete, and compliant laboratory documentation, with strong attention to data integrity and recordkeeping requirements.
- Maintain and improve SOPs, workflows, and laboratory processes; promote continuous improvement and effective risk management.
- Partner with other functions to support manufacturing operations and deliver reliable results to customers.
- Adjust schedules as needed to meet operational requirements.
QUALIFICATION AND EXPERIENCE:
- Advanced degree and at least 3 years of relevant experience, or a bachelor’s degree and at least 5 years of relevant experience, in pharmaceutical or biotechnology Quality Control.
- At least 2 years of experience in a team leadership or supervisory role.
- Degree in Chemistry, Biology, Biochemistry, Microbiology, or a related scientific field.
- Strong knowledge of cGMP, FDA regulations, ICH guidelines, quality systems, and data integrity principles.
- Experience with analytical testing methods and laboratory instrumentation, such as HPLC, GC, and dissolution testing.
- Demonstrated ability to lead and develop teams, set priorities, and maintain engagement in a demanding operational environment.
- Experience managing laboratory operations, including workload planning, scheduling, resource allocation, and process improvement.
- Proven ability to manage competing customer requirements and challenging timelines while maintaining quality and compliance.
- Strong investigation, troubleshooting, root cause analysis, and risk assessment skills.
- Experience supporting customer audits, regulatory inspections, and related follow-up activities.
- Excellent technical writing skills, including preparation and review of SOPs, investigations, and regulatory documentation.
- Proficiency with LIMS, quality management systems, and Microsoft Office applications.
- Strong communication and interpersonal skills, with the ability to engage effectively with customers and stakeholders at all levels.
- Excellent organizational and project management skills.
- Additional certifications in quality systems, regulatory compliance, or project management are an advantage.
