Deviations Specialist II

Life Technologies - Greenville, NC

Full-time - Mid Level

Greenville, NC

Miscellaneous Manufacturing

About the position

As an Investigations Specialist at Thermo Fisher Scientific, you will play a crucial role in conducting thorough investigations and implementing corrective actions to ensure compliance with Good Manufacturing Practices (GMP). Your work will involve cross-functional collaboration to identify root causes of issues, analyze trends, and develop solutions that enhance product quality and customer satisfaction. This position is integral to maintaining regulatory standards and improving operational efficiency within the organization.

Responsibilities

• Conduct 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, ensuring they are robust and pertain to assignable root causes.
• Assess the quality impact to both the patient and the product against applicable regulatory guidelines.
• Identify 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) and to impacted customers.
• 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.

Requirements

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

Nice-to-haves

• Experience in the pharmaceutical, food, or cosmetic industry.
• Strong critical thinking and problem-solving skills using logic and reason.
• Ability to perform statistical analysis when there is a large body of data.
• Project management and organizational skills to handle and prioritize multiple investigations at one time.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays
• Professional development opportunities
• Flexible scheduling options