Deviations Specialist II

at  Thermo Fisher Scientific

JOB DESCRIPTION

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.

EDUCATIONAL:

• Bachelor’s Degree within a Science and/or Engineering subject area required.
• A minimum of 2 years in a cGMP environment pharmaceutical, food or cosmetic industry
• prefer experience in technical or scientific writing principles

EXPERIENCE:

• cGMP environment pharmaceutical experience preferred, food or cosmetic industry.
• Knowledge and experience in Technical or scientific writing principles
• Validated 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 are an asset.
• Intermediate to Advanced skills in Microsoft Suite (Word, Excel, PowerPoint)
• Knowledge of adult learning methodologies; ability to coach and train others.

KNOWLEDGE, SKILLS, ABILITIES

• Be able to prepare information for the educated but uninformed reader and translate complex and scientific events into a readable document.
• Ability 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 use 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.
• Inquisitive attitude – Don’t accept obvious solutions
• Being Unbiased and Analytical – Use objectivity when looking at a problem
• Structured and Organized
• Champions Collaboration and Partnership
• Personable (Good listener and approachable)
• Adaptable to/adopt change/influencer.
• Demonstrate Company Values and have the utmost integrity.

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 specialist for root cause analysis tools (6M, Fishbone, TapRooT etc.) and general problem-solving techniques.
• 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.
• Call out 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 for investigation.
• Present investigation findings in review boards (Deviation or CAPA) as well as to the impacted customers
• Actively engage in and adhere to departmental systems 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 competence, industry knowledge and executional skills.
• Be a site champion for projects associated with improvements to investigations.
• Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, shared assets)
• Develop a culture of collaboration, flexibility, and competitiveness by growing business and scientific competence, industry knowledge and executional skills.