Supervisor, QC Investigations

at  Thermo Fisher Scientific

JOB DESCRIPTION

Job Title: Supervisor, QC Laboratory Support
Requisition ID:
When you’re part of the team at ThermoFisher 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
St. Louis, MO/Biologics Division
How will you make an impact?
The supervisor over QC Investigations will coordinate the day-to-day oversight for all the responsibilities of the QC Investigators. This team is responsible for accomplishing tasks in support of QC laboratories and support groups regarding compliance to cGMPs and GDPs. This person will provide specified instructions to staff and investigational expertise to meet the business objectives for Thermo Fisher, mentor and coach staff investigators, provide “1st Line Defense” to ensure cGMP compliance, and act as SME for the area.
What will you do?

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.

• Lead huddles or status meetings
• Assist with coordination and dissemination of investigation writing tasks to investigations personnel
• Participate in planning strategy discussions related to compliance
• Represent the group in Kaizen projects
• Lead compliance related tasks or helps with large-scale coordination of those tasks
• Facilitate discussions with clients during concurrence meetings
• Tackle critical deviation/OOS records and major deviations that need to be addressed
• Assist Scientist I and Scientist II, and help remove roadblocks to record progression
• Average 1.5 deviation/OOS/CAPA record closures per week
• Complete overdue assessments and file record extensions as required
• Author/revise SOPs (limited)
• Train testing teams on investigation outcomes to prevent recurrence of deviations
• Assist with formulating continuous improvement strategies and timelines
• Lead RAPID discussions for opening deviations and OOS records
• Participate in Gemba Walks and pre-audit inspections
• Other job duties as assigned

How will you get here?
Minimum of an Associate’s degree
Bachelor’s degree in science related field is a plus but not required
Proven track record (5 years) working in a GMP regulated environment or Quality Role (QA or QC)
Minimum of 1 year of experience in a team lead or supervisor role

Knowledge, Skills, Abilities

• Knowledge of GMP regulations
• Knowledge of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)
• Familiar with standard project management concepts, tools and responsibilities
• Abilities
• Able to read, write, and communicate in English.
• Able to use standard computer programs such as SmartSheet, PowerBI, MS Excel, Word, and PowerPoint.
• Able to drive functional, technical and operational excellence.
• Able to inspire innovation and team effectiveness.
• Able to work in an evolving environment and adapt to a variety of internal customer’s needs
• Able to de-escalate difficult situations and lead others.
• Able to recognize problems developing (not just occurring) and recognize solutions.

Skills

• Strong computer, scientific, and organizational skills.
• Strong communication skills including actively listening, conflict resolution and the ability to effectively influence diverse team members for positive outcome.
• Enjoys collaborative efforts both internal and external to the department

Physical Requirements / Work Environment:

• Wear gloves and other PPE to enter laboratory spaces
• Sit for extended periods of time. This role requires a lot of desk time and meeting time.

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, resolve difficult 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

Please refer the Job description for details