Quality Control (QC) Microbiology Specialist
Elanco
1 month ago
On-site
Elwood, KS
Operations
Quality Control (QC) Microbiology Specialist
Your Responsibilities:
- Review, approve, and report microbiological test data to ensure accuracy and compliance.
- Lead and support QC activities including deviations, investigations, and change controls.
- Author and review technical documentation such as SOPs, validation protocols/reports, specifications, study reports, and logs.
- Coordinate daily lab operations, including scheduling and task delegation across the microbiology team.
- Serve as a subject matter expert for microbiological methods, equipment, and QC processes.
- Collaborate cross-functionally with Manufacturing, Validation, and Engineering teams to support site activities.
- Perform routine release testing as well as method validation, transfer, and development work.
- Train, mentor, and provide guidance to QC Technicians and other team members.
- Ensure compliance with QC policies and identify opportunities to improve or modernize processes.
- Maintain oversight of lab materials, reagents, and equipment qualification and inventory.
- Support audit readiness and participate in internal and external audit activities.
- Drive continuous improvement initiatives within the QC laboratory.
- Provide updates in site and departmental meetings as needed.
- Support manufacturing timelines, including occasional off-hours work when required.
What You Need to Succeed (minimum qualifications):
- Education: Bachelor’s degree in Biological Sciences or closely related field (or equivalent experience).
- Experience: Minimum 5 years relevant experience (with Bachelor’s) or 10 years relevant laboratory experience.
- Top Skills: Strong microbiological testing and laboratory operations knowledge; excellent attention to detail and quality mindset; effective communicator and ability to collaborate cross-functionally in a regulated environment; commitment to safety, compliance, and quality standards; proficient in standard computer applications and systems.
What Will Give You a Competitive Edge (preferred qualifications):
- M.S. or Ph.D. in a related scientific field.
- Experience in analytical or microbiology laboratories within regulated industries.
- Prior leadership, training, or mentoring experience.
- Experience with method validation, transfer, and investigation processes.
Additional Information:
- Location: Elwood, Kansas; Full-time (FTE).
- May involve working with hazardous chemicals.
- Occasional lifting of small loads required; may include time in refrigerated environments.
- Occasional off-shift or extended hours may be required to support manufacturing.
Benefits:
- Multiple relocation packages; 8-week parental leave; 9 Employee Resource Groups; annual bonus offering; flexible work arrangements; up to 6% 401K matching.
Your Responsibilities:
- Review, approve, and report microbiological test data to ensure accuracy and compliance.
- Lead and support QC activities including deviations, investigations, and change controls.
- Author and review technical documentation such as SOPs, validation protocols/reports, specifications, study reports, and logs.
- Coordinate daily lab operations, including scheduling and task delegation across the microbiology team.
- Serve as a subject matter expert for microbiological methods, equipment, and QC processes.
- Collaborate cross-functionally with Manufacturing, Validation, and Engineering teams to support site activities.
- Perform routine release testing as well as method validation, transfer, and development work.
- Train, mentor, and provide guidance to QC Technicians and other team members.
- Ensure compliance with QC policies and identify opportunities to improve or modernize processes.
- Maintain oversight of lab materials, reagents, and equipment qualification and inventory.
- Support audit readiness and participate in internal and external audit activities.
- Drive continuous improvement initiatives within the QC laboratory.
- Provide updates in site and departmental meetings as needed.
- Support manufacturing timelines, including occasional off-hours work when required.
What You Need to Succeed (minimum qualifications):
- Education: Bachelor’s degree in Biological Sciences or closely related field (or equivalent experience).
- Experience: Minimum 5 years relevant experience (with Bachelor’s) or 10 years relevant laboratory experience.
- Top Skills: Strong microbiological testing and laboratory operations knowledge; excellent attention to detail and quality mindset; effective communicator and ability to collaborate cross-functionally in a regulated environment; commitment to safety, compliance, and quality standards; proficient in standard computer applications and systems.
What Will Give You a Competitive Edge (preferred qualifications):
- M.S. or Ph.D. in a related scientific field.
- Experience in analytical or microbiology laboratories within regulated industries.
- Prior leadership, training, or mentoring experience.
- Experience with method validation, transfer, and investigation processes.
Additional Information:
- Location: Elwood, Kansas; Full-time (FTE).
- May involve working with hazardous chemicals.
- Occasional lifting of small loads required; may include time in refrigerated environments.
- Occasional off-shift or extended hours may be required to support manufacturing.
Benefits:
- Multiple relocation packages; 8-week parental leave; 9 Employee Resource Groups; annual bonus offering; flexible work arrangements; up to 6% 401K matching.