Thermo Fisher Scientific Quality Data Analyst in Allentown, Pennsylvania

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.

Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labeling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. http://www.fisherclinicalservices.com/

What will you do?

  • Applies Good manufacturing Principles in all areas of responsibility.

  • Demonstrates and promotes the company vision.

  • Responsible for drafting Annual Product reviews and Quality Annual Report as required.

  • Responsible for generating, tracking, trending and reporting a large set of quality metrics relating to CTD- Allentown business operations and associated clients for continuous improvement purposes. These metrics include but are not limited to:

  • Quality Council Metrics

  • Client Specific Metrics

  • Global Metrics

  • Tracks open records in TrackWise to include Deviations, Complaints, CAPAs, observations and Change Controls to closure.

  • Responsible for compiling and creating presentations for local, global and clients business and quality review.

  • Identify and implement continuous improvement initiatives within the site Quality System business processes.

  • Performed statistical analysis such as regression, clustering, and hypothesis testing to uncover patterns in the data using programming language.

  • Tracks non-conformances and complaints and presents metrics to Senior Management on a scheduled basis.

  • Serves as a resource on regulatory issues, compliance, and internal investigations.

  • Conducts data analysis and data visualization to make actionable recommendations for Quality presentations.

  • Serves as quality lead in all client requested data and reporting needs from a site perspective.

  • Creates reporting, and recommended actions, for follow up on past due Quality Action Items such as Investigations etc.

  • Assist and makes recommendations with drafting and revising QA documents and Standard Operating Procedures (SOP’s) as required.

  • Provides solutions to a variety of technical problems of moderate scope and complexity with minimal supervision. Ability to develop creative ideas for simplification of day to day activities and development strategies to impact site and potential for divisional impact.

  • Conduct all activities in a safe and efficient manner.

  • Other duties may be assigned to meet business needs.

How will you get there?

  • Bachelor’s degree, preferably with a technical or life sciences focus. Statistics preferable.

  • Must have experience in GMP, and pharmaceuticals Quality system and in-depth analytical thinking and understanding of metrics management.

  • Must be able to effectively prepare reports, presentations, metrics and communications with interpretation of data analysis and potential problems with clarity and high level of accuracy.

  • Most have strong technical writing authorship and be able to review reports while effectively inputting and expressing Quality risk management risks.

  • Must be skilled in decision-making, building relationships, problem solving, planning and organizing. Must possess an independent mindset.

  • 3+ years of experience performing either data management, data analytics, data visualization, at one of the following industries is strongly preferred: Clinical research organization, technology consulting firm, pharma, medical device, or biotech organization

  • Excellent verbal and written communication and communicate effectively with customers.

Preferred Qualifications:

  • Understanding of the clinical packaging and distribution process along with awareness of regulatory documentation requirements.

  • Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.

  • Proficient in Microsoft Word, Excel, and Power Point.

  • Trackwise experience

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.