Quality Assurance Specialist IV

6 days ago


Miami, United States Thermo Fisher Scientific Full time
Role Summary

We are seeking a highly skilled Quality Assurance Specialist IV to join our team at Thermo Fisher Scientific. This role is responsible for supporting test method development, validation activities, and addressing instrumentation needs for the quality control labs.

About the Job

The successful candidate will have a minimum of 5 years of lab work experience and a strong understanding 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). They will be experienced in wet chemistry techniques, operating lab equipment, and analytical instrumentation basics, including AA/ICP, Auto-titrators, TOC, HPLC, UHPLC, ICP-MS, GC, IR, XRF and CE. Additionally, they will have working experience in systems such as LIMS, EMPower, and TrackWise.

Key Responsibilities
  • Implement method and equipment validations for the QC lab.
  • 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.
Requirements

To be considered for this role, you must have a 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 written and verbal communication and social skills at all levels are also essential. Proficiency in Microsoft Office and statistical programs (i.e. MiniTab, SAS) is preferred.

Benefits
  • A competitive salary: $93,000 per year (based on Miami, FL location).
  • Medical, Dental, & Vision benefits - Effective Day 1.
  • Paid Time Off & Holidays.
  • 401K Company Match up to 6%.
  • Tuition Reimbursement - Available after 90 Days.
  • Employee Referral Bonus.
  • Employee Discount Program.
  • Employee Recognition Program.
  • Charitable Gift Matching.
  • Company Paid Parental Leave.


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