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Work Schedule Standard (Mon-Fri)
Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards 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: Guide quality control and batch release initiatives across life science manufacturing operations while supporting a culture of compliance and continuous improvement. Manage quality control and batch release processes in a manufacturing environment to ensure products meet the highest standards. Collaborate with cross-functional teams to identify efficiencies and create robust processes, corrective and preventative actions to drive organizational advancement and increase customer service level. Develop team members to achieve operational excellence and career growth.
REQUIREMENTS: • Bachelor's degree plus 5 years of experience in pharmaceutical/biopharmaceutical quality assurance or quality control • Preferred Fields of Study: Chemistry, Biology, Engineering, or related scientific field • Comprehensive knowledge of cGMP, FDA regulations, ISO standards and other relevant regulatory requirements • Demonstrated leadership experience supervising quality teams • Direct people management: scheduling, performance management, coaching, and development of analysts. • Resource planning and workload prioritization to meet turnaround times (TAT) and release timelines. • Continuous improvement mindset (Lean, Six Sigma exposure is a plus). • Strong working knowledge of analytical techniques and understanding of method validation, transfer, and lifecycle management. • Strong expertise in quality systems including deviation management, CAPA, change control, and batch record review • Proficiency in LIMS and electronic quality systems (eQMS) practices. • Demonstrated success in root cause analysis and quality investigations • Excellent project management and organizational skills • Strong analytical and problem-solving abilities • Superior written and verbal communication skills in English • Proficiency with quality management systems and Microsoft Office applications • Experience with statistical analysis and quality metrics reporting • Ability to build collaborative relationships across functions
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Languages
- English
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