Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Able to lift 40 lbs. without assistance, 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.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials



Job Description





Sr. QC Technician



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 chances to define important 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.




Location/Division Specific Information



Miami, FL



How will you make an impact?



You will be the SR QC Technician working on teams within the Chemistry, Cell Culture, and Microbiology Laboratories. Responsible for performing chemical and/or microbiology testing on raw materials, finished products and stability samples according to applicable procedures with FDA (Food and Drug Administration), GMPs (Good Manufacturing Practices) and ISO 9001 and/or ISO 13485. Models our 4i values, integrity. Innovation, intensity, and involvement. Follows our Quality Policy by continuously improving the quality of our products & services and by ensuring global regulatory compliance.



What will you do?

• Aseptic sampling of incoming materials for testing.


• Performs quality control testing on finished products while adhering to cGLP's, cGMP's, cGDP's, and SOP's: FTIR, HPLC, Gram Stain, Growth Promotion, Bioburden, Appearance, pH, Solubility, Turbidity, Osmolality and many other Chemical and Microbiological tests as required.


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


• Collects water samples from throughout the facility to analyze samples for TOC, conductivity, and bioburden.


• Supports and collects environmental monitoring including contact plating, viable and non-viable air sampling, and media fill validations.


• Initiate OOS report and conduct investigations per applicable site procedures.


• Safe Biohazard waste handling for the QC micro lab.


• SME for raw materials QC receiving process.


• Additional duties as assigned by the Quality Lab Supervisor.

How will you get here?





Education



Bachelor's Degree or equivalent experience in QC field, e.g. engineering, chemistry, biology, or mathematics.


High school diploma or GED required with 2 years QC experience.




Experience

• Minimum of 1 - 4 years in a Chemical or Analytical testing lab in a Pharmaceutical, Biotech / Aseptic filling or similar environment.


• Multitasking in a fast-paced environment and prioritizing work is essential to success.


• Following SOPs.

Knowledge, Skills, Abilities

• Required to work on task of moderate scope where analysis of situations or data require problem solving skills.


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


• Capable of being qualified for aseptic gowning.


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


• Strong written and verbal communication and social skills at all levels.

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