*Quality Control (QC) Scientist II, Microbiologist (Environment)*
When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
*Location/Division Specific Information*
The role is responsible for Quality Control of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG). BID is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.
*How will you make an impact?*
The Quality Control (QC) Scientist II, Microbiologist (Environment) will support testing of Animal Origin-Free (AOF) enzymes intended for nucleic acid therapeutics. The primary function of this role is to ensure microbiological testing and associated investigations and reports are completed in a timely manner. 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? *
* Perform microbiological testing including bioburden, growth promotion and identification of micro-organisms.
* Ensure all microbiological procedures reflect current practice and complies with current USP/EP requirements.
* Direct the routine Environmental Monitoring program on site.
* Perform reviews of environmental monitoring data, writing summary reports and presenting findings to applicable stakeholders.
* Prepare environment monitoring risk assessments and perform qualification, as needed.
* Perform any microbial investigations required from routine EM, testing, validations, customer complaints, etc.
* Assist with validation testing of QC procedures and completion QC records/reports.
* Investigate deviations and out of specification/out of trend instances and author reports.
* Coordinate and provide training and/or opportunities for 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.
*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 2-4 years' experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products. Must have a minimum of one (1) years direct Quality Control experience.
* Understanding of GMP guidance, including 21 CFR Part 11, and Annex 11.
* Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
* 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 high level of commitment to delivering timelines and milestones to achieve business objective.
* Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems, experienced in root cause analysis.
* Ability to apply GMP regulations and international guidelines to all aspects of the position.
* Excellent communication and listening skills
* Ability to build and maintain strong collaborative relationships across multiple departments
* Microsoft Office and database management skills
* Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.
*Knowledge, Skills, Abilities (Preferred)*
* Knowledge of 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 Biotech and/or Pharmaceutical industry
* Experience with biological manufacturing processes.
* Project Management advanced experience.
* Certified Lean Professional or Six Sigma