Job Description

When your 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. We strive to bring together and develop extraordinary colleagues who share our passion for making meaningful contributions to the world.

At Thermo Fisher Scientific, each one of our 100,000 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.

Position Summary:

The candidate should have experience in performing all chemical testing on raw materials, finished products and stability samples according to applicable procedures. Also, develop and writes Standard Operating Procedures (SOPs), Test Instructions (ITs) and validation protocols. Follow the Thermo Fisher Scientific corporate standards, and best management practice.

Location/Division Specific Information

Location: Miami, Fl Site / Biologicals and Chemicals Division

Hours: Day Shift, Monday – Friday

Key Responsibilities:

·Collect environmental/utilities samples and perform analysis according to applicable site procedures. Maintain utilities trending data.

·Complete project protocols, change notifications, Deviation Waivers and Quality Notifications with minimum supervision.

·Review testing results, complete testing summary reports, and perform data entry.

·Maintain Chemistry Laboratory inventory. Order supplies, reagents, equipment, and materials.

·Responsible for maintaining laboratory notebooks and records according to Good Documentation Practices.

·Create quality tools and training materials by applying body of knowledge/expertise and by communicating it to the respective teams.

·Assist Quality Manager/Designee in the execution of internal audits and Gemba Walks as required.

·Coordinate Chemistry Lab activities in order to achieve QC testing delivery goals.

·Train other scientists on Chemistry Lab practices and procedures.

·Initiate and conduct investigations per applicable site procedures.

·Maintain Chemistry Lab audit readiness and confidentiality of all projects.

·Represents Chemistry Lab during internal and external audits.

·Perform all job duties within regulatory or statutory requirements.

·Train other scientists or QC technicians on relative tasks. Perform other related duties as assigned by QC Lab, Manager/Supervisor.

·Maintain Chemistry Lab audit readiness.

·Perform all job duties within regulatory or statutory requirements.

Your Education and Experience

·Minimum of BS degree in Life Sciences (Chemistry, Biochemistry, Molecular Biology, Microbiology) required.

·         4+ years laboratory experience.

·         Validated experience in Chemistry lab in a Pharmaceutical, Biotech/Aseptic filling environment.

·Strong knowledge of quality system regulations/requirements (i.e. ISO 9001:2000, 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.

·Working experience in the following systems: LIMS, EMPower, Chromeleon

·Should also be able to write and understand technically related protocols.

Your Knowledge Skills and Abilities

·Strong written and verbal communication skills with ability to relate across all levels of the organization.

·Effective skills in analytical thinking and problem solving.

·Ability to work in teams to obtain results, self-motivated/directed, ability to organize activities, minimal supervision required.

·Exercise judgment within generally defined practices and policies in selecting methods and techniques for acquiring solutions.

·Strong in application of technical principles, practices and procedures.

·Effective communication skills at all levels both written and verbal.

·Effective skills in analytical thinking and problem solving.

·Ability to perform multiple tasks and ability to optimally manage conflict.

·Ability to work in teams to obtain results, self-motivated/directed, ability to organize and supervise people and activities, minimal direction required.

·Proficiency in Microsoft Office and statistical programs (i.e. MiniTab, SAS)

·Education

·Strong in application of technical principles, practices and procedures.

·Excellent Benefits Package

·Review our company’s Total Rewards

·Medical, Dental, & Vision benefits-effective Day 1

·Paid Time Off & Holidays

·401K Company Match up to 6%

·Tuition Reimbursement – eligible after 90 days!

·Employee Referral Bonus

·Employee Discount Program

·Recognition Program

·Charitable Gift Matching

·Company Paid Parental Leave

·Career Advancement Opportunities

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.