Job Description

Quality Scientist

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

Location/Division Specific Information

Life Sciences Group (LSG) - BioProduction Division. Detroit, MI Peptone Manufacturing Site.

How will you make an impact?

As a Quality Laboratory Scientist, you will be responsible for the Quality Control (QC) testing and disposition of Peptone product used in critical Biopharmaceutical applications. You will also be responsible for the validation of existing and new laboratory analytical and physical test methods.

What will you do?

* Perform Quality Control (QC) chemical and biological testing of raw materials and peptone finished good products.

* Perform QC laboratory functions such as setting up, operating and maintaining laboratory equipment following standard procedures and methods.

* Responsible for documentation related to Quality Control including data analysis, recording test data, interdepartmental communications, batch history review, and creating/revising/reviewing test procedures.

* Execution and ownership of laboratory test method validations by initiating protocols and final validation reports following Q2 (R1) ICH and FDA principles.

* Write or revise standard quality control operating procedures and quality system documentation as required.

* Responsible for environmental monitoring consisting of testing, trending, and reporting for production and non-production is required as applicable.

* Write technical reports or documentation such change management records, out of Specification analyses and data trending.

* Assist in purchasing of lab supplies as required and support of subcontractors activities related to lab requirement.

* Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.

* Support manufacturing batch record review for adherence to Good Manufacturing Practices (GMP) and site procedures and perform quality monitoring rounds on the manufacturing floor.

How will you get here?

Education

* Bachelor of Science (BS) Degree in Analytical Chemistry or Biochemistry or Biology/Microbiology education is a plus.

* Bachelors degree desired, high school diploma/GED is minimum requirement.

Experience

* A minimum of 2 years prior experience in a Quality Control Laboratory setting in the Pharmaceutical/Biotech/or Life Science industry.

* Prior experience with the release and disposition of product through the application of analytical/physical/ or microbiological methods.

* Good analytical skills, with an ability to use scientific knowledge and statistical methods to conduct laboratory OOS investigations.

* Successfully introduced and validated new analytical and/or biological test methods through the initiation and execution of test method validation protocols and reports.

* Demonstrated validation proficiency, with knowledge of equipment qualification (IQ/OQ/PQ) is a plus.

* Prior experience with the development and /validation of standard analytical methods such as HPLC, FTIR, TLC and ICP-MS desired.

Knowledge, Skills, Abilities

* Knowledge of cGMP regulations and ISO guidelines.

* Familiarity with Q2 (R1) ICH principles.

* Knowledge of test method development and validation.

* Excellent organization skills with strong attention to details.

* Good verbal and written communication skills.

* Ability to multitask efficiently to support production demand.

* Computer skills: knowledge of Microsoft Office applications (Work, Excel and PowerPoint) is a must.

* Knowledge of statistical methods is a plus.

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

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