**Work Schedule** First Shift (Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards **Job Description** **Job Title:** **Lead Document Control Administrator (QAD)** **Job Description:** **Work Shift 1st Shift (Monday-Friday)** **Requisition ID:** At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building an exciting career with us. **Location/Division Specific Information** This role is based in St. Louis, MO, within our multifaceted division dedicated to the production of commercial and clinical biologics. **Discover Impactful Work:** Join our team and contribute to pioneering projects that have real-world impact. As a Lead Document Control Administrator, you will play a crucial role in ensuring detailed documentation processes, supporting our mission to deliver extraordinary solutions. **A day in the Life:** + Coordinate shift exchanges, meetings, and attend important meetings to address area needs and changes. Also, participate in lean activities, cross-functional activities, and shift huddles. + Provides coverage in supervisor absences and delegate duties efficiently to support production demands. + Schedule daily/weekly department assignments. + Function as liaison with other groups within the organization and serve as a qualified trainer for department processes, procedures, audits, and inspections. + Assist in the creation, implementation, and maintenance of department training curriculum, and train new/current colleagues. + Maintain up-to-date training records and qualified trainer certification. + Initiate and approve deviations, complete CAPA requirements, perform SOP revisions, and implement new processes within the department. + Support audits (internal/external), inspections, and applicable preparation & closure activities. + Document all activities to meet cGMP requirements and maintain cGMP compliance in assigned work while following all safety procedures. + Perform all document-related tasks such as making documents effective, printing, periodic review, withdrawal, reconciliation, issuance, archiving, scanning, record retention, document release, and accountability. + Generate applicable reports and data to support departmental metrics and job functions. + Align with all job-related safety and other training requirements. + Support 24/7 coverage as needed, including evenings, weekends, and holidays. + Participate in other required activities (i.e. perform safety inspections, participate in improvement projects, other documentation processes, etc.). **Keys to Success:** + Strong organizational and prioritization skills. + Diligent with a focus on safety. + Ability to work independently and as part of a team. **Education** + Bachelor’s degree preferred. **Experience** + At least 2 or more years of relevant experience in quality, manufacturing, and/or GMP environment preferred. + At least 1 or more years of leadership experience. **Knowledge, Skills, Abilities** + Digital literacy, including experience in using Smartsheet, SAP, Trackwise, and MS Office applications like Word and Excel. + Proficient in computer systems associated with quality assurance functions, such as document searches, review and approval, sample labels (LIMS), batch record release, and document issuance. + Strong communication skills to establish and maintain positive relationships with employees and the public, demonstrating tact in handling sensitive matters. + Excellent attention to detail and interpersonal skills. + Self-motivated, mature, independent, and detailed. + Capable of growing in a fast-paced environment, prioritizing multiple tasks simultaneously. **Physical Requirements / Work Environment** + The position requires basic physical skills like walking, standing, and bending, as well as the ability to lift and carry light to medium weights. It also requires good hand and finger dexterity for typing, and clear vision for using a computer and reading. **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. **Apply today! http://jobs.thermofisher.com** Apply today! http://jobs.thermofisher.com _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._ 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.