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Über
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Work Schedule: Standard (Mon-Fri) Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards Location: Detroit, MI. Relocation assistance is NOT provided. *Must be legally authorized to work in the United States without sponsorship. *Must be able to pass a comprehensive background check, which includes a drug screening. A Day in the Life: Manage quality control and batch release processes in a manufacturing environment Lead a team of laboratory QC Scientists and Quality specialists responsible for testing and product releases Improve throughput and quality metrics for QC laboratory Ensure products meet the highest standards Identify inefficiencies 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. Collaborate with cross-functional teams to support a culture of compliance and continuous improvement. Minimum Requirements: Education: Minimum Required Education: Bachelor degree (Preferred Fields of Study: Chemistry, Biology, Engineering, or related scientific field) Experience: 3+ years of quality assurance or quality control experience 2+ years of quality leadership/ management experience within a regulated industry (i.e. performance management, scheduling and coaching etc.) Pharmaceutical/biopharmaceutical industry experience preferred Experience with statistical analysis and quality metrics reporting Knowledge, Skills, Abilities: Comprehensive knowledge of cGMP, FDA regulations, ISO standards and other relevant regulatory requirements 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 Ability to build collaborative relationships across functions Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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