Scientist 3 (Technical Writer)

Thermo Fisher Scientific - St. Louis, MO (30+ days ago)3.6


Job Description
Scientist 3 – QC Technical Writer

Requisition ID: 66865BR

Summary:
Prepare new documents as per ICH guidelines for Biopharmaceutical Drug Substance such as specs, Qualification plans/reports, Validation/Verification protocols/reports, and Method Transfer protocol/reports. Revises and updates standard operating procedures and test methods as needed.

Essential Functions:
Authors, reviews qualification, validation, method transfer documents.
Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA.
Complies with all company and site policies and procedures. Reports any non-conformances. Initiates and/or leads resolution efforts and laboratory investigations.
Trains junior level staff in analytical method transfer.

Job Scope:
Effective oral and written communication skills.
Working knowledge of cGMPs and Quality Control regulatory requirements
Experience with authoring documents for qualification/validation of QC assays.
Performs analytical and technical troubleshooting
Timeline driven
Client facing

Experience:
Bachelor’s Degree in a Science related field; will consider Associate's degree with considerable more years of experience in a biopharmaceutical lab environment
5+ years of experience in method validation and method qualification.
Prior experience authoring documents for qualification/validation of QC assays
Experience performing analytical and technical troubleshooting
Prior experience in a GMP environment highly preferred with a working knowledge of cGMPs and Quality Control regulatory requirements.
Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred.
ELISA experience with large molecules is strongly preferred.
Routine use of MS Excel, MS PowerPoint, and MS Word is essential

Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.

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.

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.