Work ScheduleStandard (Mon-Fri)
Environmental ConditionsLaboratory Setting
Job DescriptionDivision/Site Specific InformationPosition is based High Point, North Carolina. Position will support our Drug Product Division (DPD) at Thermo Fisher Scientific.
A Day in the Life- Oversee testing operations including raw materials, in-process controls, environmental monitoring, and finished product release.
- Support data integrity and Good Manufacturing Practices (GMP) while developing team members through mentoring and training.
- Ensure laboratory readiness for regulatory inspections and customer audits while improving operational efficiency through quality metrics and process improvements.
Keys to Success:Education:- BS Degree required. Preferred Fields of Study: Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field.
- Advanced degree preferred.
Experience:• Advanced degree plus 6 years of experience, or Bachelor's degree plus 8 years of experience in regulated pharmaceutical or biotech industry quality control.
• 5+ years of people management experience leading QC laboratory teams.
• Experience managing laboratory investigations, deviations, and CAPA processes.
• Experience with laboratory information management systems (LIMS) and data integrity requirements.
• Experience supporting regulatory inspections and customer audits.
Knowledge, Skills, Abilities:• Extensive knowledge of cGMP regulations, quality systems, and regulatory requirements, including FDA, EMA, and ICH.
• Strong understanding of analytical testing methods and laboratory operations.
• Demonstrated success implementing and improving quality systems and processes.
• Leadership experience developing and mentoring staff.
- Effective project management and organizational skills.
• Clear written and verbal communication skills.
• Proficiency with standard business software, including MS Office, and quality systems.
• Ability to adapt to changing priorities.
• Sound problem-solving skills and scientific decision-making abilities.
• Commitment to workplace safety and compliance.
• Effective client communication skills.
