Supervisor, Deviation Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our collaborative team at Thermo Fisher Scientific as a Manufacturing Sciences Supervisor, where you'll guide technical operations in a GMP-regulated environment. You'll support a team of scientists and engineers while serving as the technical owner for customer programs in manufacturing. Working at the intersection of process development and production, you'll contribute to innovation and excellence in bioprocessing technologies while ensuring compliance with quality standards. This role offers the opportunity to contribute to life-changing therapies while developing your leadership skills in an innovative organization.

How will you make an impact?
As a Deviation Supervisor, you will be responsible for the timely completion of investigations. By working cross-functionally between various groups, your team will focus on the identification of root cause(s), trend analysis as well as identification of corrections, corrective actions, and preventative actions (CAPA) to assist in the reduction or elimination of reoccurrence of investigations.

Key Responsibilities:

• Conducting thorough and structured investigations through data collection, collaboration, and analysis
• Work on the manufacturing and/or laboratory floor to gather data and observe processes.
• Be a method SME for root cause analysis tools (6M, Fishbone, TapRooT etc.) and general problem-solving techniques.
• Lead, initiate, and assist with the completion of immediate corrections and CAPA items as well as ensuring that CAPA items are robust and pertain to the assignable root causes.
• Ensure that the quality impact to both the patient as well as the product is assessed against applicable regulatory guidelines.
• Escalate activities and barriers associated with investigation planning and completion.
• Write reports and summaries clearly and promptly to ensure timelines are met.
• Compile Key Process Indicators (KPIs) for investigation.
• Present investigation findings in review boards (Deviation or CAPA) as well as to the impacted customers
• Be a site champion for projects associated with improvements to investigations.
• Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, shared assets)
• Champion a culture of collaboration , flexibility and competitiveness by increasing business and scientific acumen, industry knowledge and executional skills.
• Mentor and train junior staff members.
• Provide oversight of completion of investigations
• Provide investigation guidance and expertise for complex deviations to all teams on site.

Core Qualities and Competencies:

• Be able to prepare information for the educated but uninformed reader and translate complex and scientific events into a readable document.
• Be able to perform statistical analysis when there is a large body of data.
• Strong critical thinking and problem-solving skills by using logic and reason.
• Understand and utilize risk analysis skills.
• Proactively identify area(s) of improvement within a system or process
• Strong communication skills to facilitate of meetings to gain internal alignment on root cause(s) and CAPA; may need to be regulatory authority or customer facing.
• Ability to resolve conflict in a cross functional setting.
• Project management and organizational skills to handle and prioritize multiple investigations at one time.

Personality Attributes:

• Inquisitive attitude – Don’t accept obvious solutions
• Being Unbiased and Analytical – Use objectivity when looking at a problem
• Structured and Organized
• Fosters Collaboration and Teamwork
• Personable (Good listener an approachable)
• Adaptable to/embrace change/influencer
• Demonstrate Company Values and have the utmost integrity.
• Leadership and goal oriented in other being successful.

Personal Traits to avoid:

• Someone who prefers to work in an isolated role.
• Those that are, argumentative, overly emotional, biased, gullible, passive, easily persuaded or willing to accept the first solution without question.

Educational and Experience Requirements:

• Bachelor’s Degree within a Science and/or Engineering discipline
• A minimum of 5 years in a cGMP environment pharmaceutical, food or cosmetic industry
• A minimum of 3-year experience in technical or scientific writing principles
• Demonstrable knowledge of cGMP principles pertaining to investigations and CAPA actions
• Experience in practical problem solving and continuous improvement projects.
• Experience and proficiency with TrackWise and TapRooT or other Root Cause Tools
• Intermediate to Advanced skills in Microsoft Suite (Word, Excel, PowerPoint)
• Knowledge of adult learning methodologies; ability to coach and train others.
• Experience with training technical writing skills and Root Cause Analysis Tools

Physical Demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as- dust, fumes or odors, temperature extremes, loud noise, strong drafts or bright lights.

Work Environment:

This job operates in a professional office environment as well as the Production, Laboratory and Warehouse environment in a pharmaceutical facility. This role routinely uses standard office equipment such as computers, phone, photocopiers, filing cabinets and fax machines.

Disclaimer:

This is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Other duties may be assigned as needed.