Thermo Fisher Scientific QC Scientist – Biochemistry & Biology Job

Thermo Fisher Scientific QC Scientist – Biochemistry & Biology Job

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them

Title: Engineer/Scientist I, QC

Location Carlsbad, California, US

Job ID: 192905BR

How will you get here?

  • Bachelor’s degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology, or Biomedical Engineering. Microbiology degree strongly preferred.
  • Minimum of 1-3 years experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products.
  • Experience with and knowledge of related quality systems such as Change Control; CAPA (including Deviations/OOSs); Training; and Document Control.

Knowledge, Skills, Abilities (Required)

  • Experience performing laboratory investigations.
  • Must demonstrate a commitment to delivering timelines and milestones to achieve business objective.
  • Excellent communication and listening skills.
  • Ability to build and maintain strong collaborative relationships across multiple departments.
  • Microsoft Office and database management skills.
  • Working knowledge of cGMPs and global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems in the Biotech and/or Pharmaceutical industry.
  • Experience with biological manufacturing processes.

How will you make an impact?

The Engineer/Scientist QC, Raw Materials/Incoming Inspection will support testing of Animal Origin-Free (AOF) enzymes intended for nucleic acid therapeutics. This is a unique opportunity positioned to help build manufacturing capabilities from the ground up with direct impact to something relevant worldwide, right now; being part of the supply chain for vaccine production.

What will you do?

  • Test incoming raw materials or perform incoming inspection per established processes and AQL sampling sizes.
  • Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems.
  • Clearly and accurately communicate the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of the analysis in accordance with prescribed lab procedures and systems.
  • Perform laboratory duties as required along with maintaining and interpreting trending of test data.
  • Create summary reports of trending data.
  • Assist with validation testing of QC procedures and completion of QC records/reports.
  • Investigate deviations and out-of-specification/out-of-trend instances, define and implement CAPAs as required, and author reports.
    Coordinate and provide training and/or opportunities for the career development of others.
  • Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences.
  • Perform other duties as assigned.

Thermo Fisher Scientific QC

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