Engineer/Scientist II, QC

Oxoid Remel Microbiology (Acquired from Thermo Fisher Scientific)

Lenexa (KS)

On-site

USD 65,000 - 88,000

Full time

11 days ago

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Job summary

Oxoid Remel Microbiology seeks an Engineer/Scientist II to support the Quality Control Organisms Laboratory in Lenexa, Kansas, focusing on finished-product testing, regulatory compliance, and continuous improvement. You will ensure products meet testing standards, IFUs, SOPs, and regulatory guidelines while collaborating with QC leadership.

The role combines hands-on testing with documentation review, root-cause investigations, and process improvements, requiring teamwork and adherence to GLP,

Qualifications

  • Bachelor's degree in Biological Sciences or related field.
  • Experience in a microbiology laboratory environment.
  • Familiarity with FDA regulations for medical devices.
  • Understanding of USP and CLSI requirements.
  • Strong organizational and time management skills.
  • Proficiency in MS Office.
  • Ability to follow written and verbal instructions and lab procedures.
  • Strong analytical, critical-thinking, and problem-solving skills.
  • Excellent written and verbal communication in English.

Responsibilities

  • Support finished-product testing and laboratory investigations.
  • Review and maintain product compliance specifications and lab documentation.
  • Ensure testing activities follow SOPs and regulatory requirements.
  • Maintain accurate lab records for traceability and compliance.
  • Collaborate with QC leadership and cross-functional teams on investigations and improvements.
  • Develop and execute protocols supporting productivity and process improvement.

Skills

English communication
Analytical skills
Team collaboration
Documentation
Time management

Education

Bachelor's degree in Biological Sciences
Bachelor's degree in Microbiology

Tools

MasterControl
SAP
Microsoft Office

Job description

Make an Impact

Joining Oxoid Remel Microbiology means becoming part of a team dedicated to making a meaningful difference in healthcare, food safety, and pharmaceutical manufacturing. Our products and solutions support accurate disease identification, targeted treatment, and reliable microbiology testing around the world.

As an Engineer/Scientist II - Quality Control, you'll play an important role in ensuring the quality, performance, and reliability of our microbiology products. You'll support finished-product testing, laboratory investigations, and continuous improvement initiatives while working closely with Quality Control leadership and cross-functional teams.

About the Role

The Engineer/Scientist II is responsible for supporting the daily activities of the Quality Control Organisms (QCO) Laboratory in Lenexa, Kansas, with a focus on finished-product testing, regulatory compliance, laboratory productivity, and continuous improvement.

You’ll ensure finished products meet established testing standards, Instructions for Use (IFUs), Standard Operating Procedures (SOPs), customer requirements, and applicable regulatory guidelines.

This role combines hands-on laboratory testing with project coordination, documentation review, root cause investigations, and process improvement activities.

What You Will Do
Quality Control Testing & Laboratory Operations
  • Perform finished-product quality control testing to ensure compliance with established specifications, IFUs, SOPs, and regulatory requirements.
  • Provide routine hands-on laboratory bench coverage alongside other Quality Control team members.
  • Review and maintain product compliance specifications and laboratory documentation.
  • Ensure testing activities are performed accurately and efficiently in accordance with established procedures.
  • Maintain accurate laboratory records to support product quality, traceability, and compliance.
  • Support departmental testing priorities and assist QC leadership as needed.
Quality Systems & Regulatory Compliance
  • Ensure laboratory activities comply with applicable FDA and ISO requirements, Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).
  • Review laboratory procedures and identify opportunities for updates or improvements.
  • Prepare proposed revisions and redlines to SOPs for QC leadership review and approval.
  • Maintain required training and documentation within MasterControl.
  • Follow established laboratory safety requirements, quality procedures, and company policies.
  • Maintain an understanding of applicable USP and CLSI testing requirements.
Scientific Investigations & Problem-Solving
  • Support root cause investigations related to laboratory testing, product performance, and quality concerns.
  • Assist in evaluating unexpected testing results, process issues, and opportunities for corrective action.
  • Apply scientific principles, critical thinking, and data analysis to investigate laboratory challenges.
  • Collaborate with QC leadership and cross-functional teams to identify solutions and resolve quality issues.
  • Document investigation activities and findings in accordance with established procedures.
Continuous Improvement & Productivity Projects
  • Develop, write, and execute protocols supporting laboratory productivity and process improvement projects.
  • Support continuous improvement initiatives under the direction of QC leadership.
  • Identify opportunities to improve laboratory efficiency, workflow, testing practices, and documentation accuracy.
  • Participate in project reviews, analyze results, and communicate findings and recommendations.
  • Collaborate with laboratory team members and other departments to implement improvements.
  • Support departmental performance objectives and continuous improvement goals.
Collaboration & Teamwork
  • Work closely with QC leadership and laboratory colleagues to support daily operational priorities.
  • Communicate effectively with cross-functional teams regarding testing activities, investigations, and improvement projects.
  • Maintain a collaborative and flexible approach in a fast-paced laboratory environment.
  • Demonstrate accountability, initiative, and a commitment to meeting department objectives.
  • Perform additional responsibilities as needed to support laboratory operations.
Minimum Qualifications
  • Bachelor's degree in Biological Sciences or a related scientific discipline.
  • Previous experience working in a microbiology or related laboratory environment.
  • Familiarity with FDA regulations applicable to medical devices.
  • Understanding of USP and CLSI requirements.
  • Strong organizational and time management skills, with the ability to manage multiple priorities.
  • Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
  • Ability to follow written and verbal instructions and established laboratory procedures.
  • Strong analytical, critical-thinking, and problem-solving skills.
  • Excellent written and verbal communication skills in English.
  • Ability to collaborate effectively with laboratory personnel and cross-functional teams.
  • Willingness to work overtime and weekends when required to support business needs.
Preferred Qualifications
  • Bachelor's degree in Microbiology.
  • 5+ years of microbiology laboratory experience, including project management and project review experience.
  • Experience in an FDA-regulated medical device, diagnostics, or similarly regulated laboratory environment.
  • Knowledge of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
  • Experience supporting finished-product testing, quality investigations, and laboratory documentation.
  • Experience writing and executing laboratory protocols and updating SOPs.
  • Familiarity with MasterControl or similar quality management systems.
  • Experience using SAP.
  • Experience supporting continuous improvement or laboratory productivity initiatives.
Working Environment
  • Work is performed onsite in a Quality Control laboratory in Lenexa, Kansas.
  • The position requires regular hands-on laboratory testing and collaboration with QC team members.
  • Standard working hours are generally Monday-Friday; however, schedules may change based on business needs.
  • Overtime and weekend availability may be required to support testing priorities.
  • Employees are expected to follow applicable laboratory safety procedures and quality standards.
Join Us

This is an exciting opportunity to join Oxoid Remel Microbiology and contribute to the quality and reliability of products that support important microbiology and diagnostic testing around the world.

You’ll have the opportunity to strengthen your scientific expertise, participate in laboratory investigations, contribute to continuous improvement projects, and collaborate with experienced professionals committed to quality and operational excellence.

If you're a motivated scientific professional who enjoys hands-on laboratory work, solving problems, and improving processes, we'd love to hear from you.

Come be part of what's next at Oxoid Remel Microbiology.

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