Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (
GMP) Safety Standards, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)
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.
Position Summary
The Finished Product / Stability QC Supervisor is responsible for leading a Quality Control team in a cGMP-regulated environment, ensuring compliance with all regulatory requirements and internal quality standards. This role provides technical leadership and oversight of laboratory operations supporting pharmaceutical manufacturing, including finished product release and stability testing programs.
The supervisor drives operational excellence through team development, workflow optimization, and continuous improvement initiatives, while maintaining a strong focus on quality, compliance, and data integrity.
Key Responsibilities
- Lead and supervise QC analysts supporting finished product release and stability testing
- Ensure compliance with cGMP, FDA regulations, ICH guidelines, and internal quality systems
- Oversee laboratory operations including scheduling, resource allocation, and workload prioritization
- Provide technical expertise in analytical testing methods (e.g., HPLC, GC, dissolution)
- Manage and prioritize stability testing programs to meet critical deadlines
- Review and approve laboratory data, investigations, and technical documentation
- Lead and support OOS, OOT, deviations, and root cause investigations
- Mentor, coach, and develop team members to foster a strong quality culture
- Support regulatory inspections and audits, ensuring inspection readiness at all times
- Drive continuous improvement initiatives to enhance efficiency, compliance, and data quality
- Ensure adherence to data integrity principles and proper documentation practices
- Collaborate cross-functionally with Manufacturing, QA, and other stakeholders
- Utilize LIMS and quality systems for data tracking, reporting, and compliance
Minimum Qualifications
- Education & Experience:
- Advanced degree with 3+ years of relevant experience, or
- Bachelor’s degree with 5+ years of experience in pharmaceutical/biotech QC
- Minimum 2 years of leadership or supervisory experience
- Field of Study:
- Chemistry, Biology, Biochemistry, Microbiology, or related scientific discipline
Preferred Qualifications
- Certifications in quality systems, regulatory compliance, or project management
- Experience with LIMS and quality management systems
- Experience supporting regulatory audits and inspections
Required Skills & Competencies
- Strong knowledge of cGMP, FDA regulations, and ICH guidelines
- Expertise in release chemistry and stability testing requirements
- Proficiency with analytical instrumentation (HPLC, GC, dissolution, etc.)
- Strong technical writing skills (SOPs, investigations, regulatory documents)
- Proven leadership and team development capabilities
- Excellent problem-solving and root cause analysis skills
- Strong organizational and project management abilities
- Effective communication and interpersonal skills across all organizational levels
- Working knowledge of data integrity and documentation practices
- Ability to manage multiple priorities while maintaining high-quality standards
- Proficiency in Microsoft Office applications
- Flexibility to support manufacturing schedules as needed
Work Environment & Expectations
- Operates in a regulated laboratory environment supporting pharmaceutical manufacturing
- Requires adaptability to shifting priorities and production timelines
- Strong emphasis on quality, compliance, and continuous improvement