Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials
Job Description
Job Title: Engineer/Scientist III, QC
When you're part of the team at Thermo Fisher Scientific, you'll do important work. As we continue to grow, you'll have career advancement opportunities and learning in an environment that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make meaningful contributions to the world. Now is an exciting time to join manufacturing team! We are dedicated to ensuring our customers receive the products they need to achieve their scientific goals quickly and safely.
How will you make an impact?
The Scientist III - QC is responsible for supporting test method development for the QC labs and validation activities as well as addressing instrumentation needs for the lab. This role can perform all chemical and microbiological testing on raw materials, finished products and stability samples according to applicable procedures. They can provide regulatory and International Standards guidance and support. Models our 4i values, integrity, innovation, intensity, and involvement. Aligns with our Quality Policy by continuously improving the quality of our products & services and by ensuring global regulatory compliance.
Location/Division Specific Information
Miami, FL - BioProduction Division
Position is for 1st shift, 8am to 5pm, Monday - Friday
What will you do?
Implement method and equipment validations for the QC lab. Ensure all requirements for products, processes, and systems will be fulfilled. Use specialized technical knowledge and skills to make detailed observations and analyze data to ensure QC analytical results are within operating parameters. Provide innovative technical solutions required to meet business objectives with emphasis on efficiency and a risk based approach.
Ensure test method verification and validation requirements are reviewed and defined appropriately.
Perform analysis on environmental/utilities. Maintain utilities trending data.
Complete project protocols, change notifications, Deviation Waivers and Quality Notifications with minimum supervision.
Review, complete and document testing results and testing summary reports. Serves as SME for QC analytical processes and instrumentation use. Can effectively troubleshoot instrumentation issues and evaluate test method transfer effectiveness.
Create quality tools and training materials by applying body of knowledge/expertise and by communicating it to the respective teams.
Review, develop and write Standard Operating Procedures (SOPs), Test Instructions (ITs) and validation protocols.
Train and mentor other scientists and technicians on Lab testing practices and procedures as well as other relative tasks.
Initiate and conduct investigations on out of specification results.
Represents Lab during internal and external audits. Respond to QC lab related audit observations and identifies and implements appropriate corrective and preventive actions.
Other related tasks as assigned by QC Lab, Manager/Supervisor.
Minimum Requirements/Qualifications
Minimum of BS degree in Life Sciences (Chemistry, Biochemistry, Molecular Biology, Microbiology) with 5 years of lab work in college course work and/or professional experience.
Strong knowledge of quality system regulations/requirements (i.e. ISO 9001/13485, 21 CFR Part 211/ 210, Part 601/610, Part 1271, Part 820 and cGMP/GLP and USP, EPA regulations).
Experience with wet chemistry techniques and operating lab equipment such as Balances, Ovens & Spectrophotometers.
Experience with testing USP, EP, ACS test methods and monographs.
Analytical instrumentation basics required and hands-on experience for AA/ICP, Auto-titrators, TOC, HPLC, UHPLC, ICP-MS, GC, IR, XRF and CE. Ability to troubleshoot lab instrumentation.
Working experience in the following systems: LIMS, EMPower, and TrackWise.
Knowledge, Skills, Abilities:
Ability to work independently or in teams to obtain results, self-motivated/directed, ability to coordinate activities. Minimal to no supervision required.
Experience in applying standard approaches to lead change.
Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Strong written and verbal communication and social skills at all levels.
Proficiency in Microsoft Office and statistical programs (i.e. MiniTab, SAS) preferred.
What Thermo Fisher Offers to Employees:
Incredible Benefits!
Review our company's Total Rewards
Medical, Dental, & Vision benefits - Effective Day 1
