Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
This position supports the QC Analytical team for our Biologics Division in St. Louis, MO.
How will you make an impact?
The QC Analytical Supervisor will be responsible for managing the weekend (Fri-Mon) team of laboratory analyst and data reviewers. This position offers the chance to lead a newer developed team within a rapidly growing site, surrounded by collaborative colleagues and supported by an exceptional organizational strategy.
What will you do?
Manage Weekends (Fri-Mon) scheduling for both analytical testing and data review.
Author, review, and approve laboratory raw data, Laboratory Incidents (Invalid Assays), Deviations, OOS and OOT investigations.
Support the engineering and validation teams' tasks to assist with equipment commissioning and decommissioning actions, including change controls.
Perform or schedule laboratory walkthroughs focused on compliance, safety, and efficiency.
Provide leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
Author and/or revise internal procedures, test methods, specifications, and other QC documents.
Review and approve Certificate of Testing, validation reports, and other analytical reports.
Provide support to site Safety initiatives.
Other job duties as assigned.
How will you get here?
Bachelor's Degree in a Biological Science related field.
Industry Experience
5+ years of experience working in a GMP facility and/or regulated environment and in a Quality Control Role.
3+years' experience working in a role performing analytical testing on pharmaceutical product(s).
At least one year experience with analytical method lifecycle (development, qualification, transfer, and/or validation)
Knowledge, Skills, Abilities
Routine use of MS Excel, MS PowerPoint, MS Teams, and MS Word is essential.
Ability to understand customer requirements related to Quality control, including processes and equipment.
Ability to perform structured problem-solving techniques in an analytical laboratory.
Outstanding technical writing skills.
Strong interpersonal skills including actively listening, conflict resolution and the ability to effectively influence diverse stakeholders for positive outcome.
Highly organized with attention to detail.
Ability to drive functional, technical and operational excellence.
Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
Physical Requirements / Work Environment:
Must be able to cover Friday-Monday, 10 hr shifts.
Ability to lift up to 25 lbs independently, with occasional heavier objects of up to 50lbs with assistance.
Must be able to wear gloves and other PPE to handle samples.
Must be able to stand for extended periods of time, as needed.
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
Disclaimer:
This job description presents the general content and requirements for the performance of this job. The description is not to be construed as an extensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to describe an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully abide by all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Thermo Fisher Scientific is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We strive to build an inclusionary work environment and prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.