**Work Schedule** Second Shift (Afternoons) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office **Job Description** **Shift schedule:** 2nd shift, 2:00 PM -10:30 PM **What will you do?** + Demonstrates and drives the Thermo Fisher values – Integrity, Intensity, Involvement, and Innovation (The Four I’s). + Applies current Good Manufacturing Principles and Quality Management Systems (QMS) in all areas of responsibility. + Creates, monitors, and controls all logbooks for completeness, review, and accuracy on an annual basis. + Generates Standard Operating Procedures, Work Instructions, Master Forms, checklists that support company goals and objectives. + Continually improves processes to operate in the highest state of efficiency and control and in line with Fisher’s PPI processes. + Cultivates collaboration and partnership within the organization and with customers. + Trains new associates. + Performs detailed batch record reviews daily. + Performs pack out operations efficiently and accurately by packing labels into boxes as per specific customer profiles. + Conducts weekly Gemba walks to observe and improve processes. + Runs the metrics and sends out batch record errors monthly. + Reviews and signs off on batch record dispositions. + Ensures adherence to Good Documentation Practices (GDP) and Data Integrity (DI) standards. + Performs inspections of in-process (IP) materials for shipping. + Leads tier meetings as requested by management. + Conducts periodic reviews of procedures and reports. + Provides constructive feedback to quality management to drive continuous improvement. + Works collaboratively with other departments to resolve issues encountered during final release to ensure the release of labels meets customer requirements. + Assists with all quality operation tasks, as assigned. **How will you get here:** + Bachelor’s degree in relevant fields of study such as life science, computer science, engineering, or business administration with at least 3 years' experience in a Quality role OR Associate degree with at least 5 years’ experience in a Quality role. + Thorough understanding of QA processes, including Internal Audits, Document Control, Deviations, and Change Control. + Analytical Skills: Ability to analyze data, identify trends, and derive meaningful insights. + Attention to Detail: Meticulous in identifying defects and ensuring product quality. + Problem-Solving Skills: Capability to troubleshoot issues and implement effective solutions. + Strong verbal and written communication skills for reporting and collaboration. + Ability to lead and empower a team, handle difficult situations. + Technical Skills: Proficiency with QA tools, software testing frameworks, and methodologies. + Quality Standards: In-depth understanding of industry-specific quality standards and regulations (e.g., ISO, Six Sigma). + Time Management: Efficiently handling time to meet client timelines and project achievements. + Critical Thinking: Ability to think critically and make decisions based on data and evidence. + Multitasking: Ability to prioritize multiple projects and tasks simultaneously. + Adaptability: Flexibility to adapt to changing requirements and environments. + Teamwork: Ability to work efficiently with cross-functional teams including developers, product managers, and collaborators. Preferred Experience and Skills + Any Quality-related certification. **Compensation and Benefits** The hourly pay range estimated for this position based in New York is $25.60–$38.40. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: + A choice of national medical and dental plans, and a national vision plan, including health incentive programs + Employee assistance and family support programs, including commuter benefits and tuition reimbursement + At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy + Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan + Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.