Job Description

When you2019re part of the team at Thermo Fisher Scientific, you2019ll 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 you2019ll be supported in achieving your career goals.

Location/Division Specific Information

The BioProduction Division is one of the fastest growing businesses in the company, supporting developers and manufacturers of biological-based therapeutics and vaccines. 200BWith our portfolio of best-in-class products that span the bioprocessing workflow from discovery through large-scale commercial production, our business is driving performance in bioprocessing through collaboration with our customers.

How will you make an impact?

Within the Quality organization of the Chelmsford, MA facility, we are seeking an organized Quality Control Lab Investigator who will be motivated by this exciting opportunity for a detail-oriented professional to develop their investigation and Quality System skills, supporting QC by conducting and documenting OOS and deviation investigations and CAPA. This position also helps to improve QC systems through SOP writing and revision, and reviews some analytical data, as needed.

Day Shift- Monday- Friday

What will you do?

Supporting the Quality Organization, the QC Lab Investigator will:

* Execute and document thorough, detailed OOS and deviation investigations
* Assist with the development and execution of CAPAs
* Use Trackwise software for the documentation of Quality System activities
* Author and revise Quality Control SOPs
* Review laboratory operations and identify continuous improvement opportunities for Quality related process/procedures/documents
* Review analytical data for completeness and accuracy, as needed
* Work independently and as part of a team.

How will you get here?

Education and Experience

* Bachelors or equivalent degree from accredited college/university in relevant scientific discipline.
* Minimum of 2 years of relevant experience in a GMP or ISO environment.
* Previous experience with Trackwise software is desirable

Knowledge, Skills, Abilities

* Understanding of common root-cause investigation tools (i.e. 6Ms, 5 Whys, Fishbone diagrams, etc.)
* Ability to conduct and document interviews with personnel to gather a complete picture of the relevant information related to an event
* Excellent writing skills
* Knowledge of Quality standard (e.g., ISO 13485, FDA, ICH) guidelines
* Familiar with SAP, Agile, E1, LIMS or other electronic data/document management systems.
* Flexibility to adapt to a dynamic environment and manage activities to meet the needs of the business while maintaining a focus on quality.
* Excellent inter-personal, communication and organizational skills with good attention to detail.