Senior Microbiologist, GMP QC: Lead Microbiology & CAPA

Millipore Corporation; Carlsbad (CA); On-site; USD 66,000 - 99,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Job summary

MilliporeSigma is seeking a Senior Microbiologist to join the Quality Control Microbiology team in a GMP viral-vector manufacturing environment. You will lead microbiology testing and environmental monitoring efforts, implement methods and equipment, and drive technical studies and investigations.

You will provide direction to analysts and collaborate with Manufacturing, QA, Process Development, Engineering, Validation, and client teams to deliver compliant, reliable results, while supporting

Qualifications

• Bachelor's degree in a life-science field required.
• 7+ years in a regulated GMP microbiology lab for biologics/viral-vector products.
• Experience with investigations, CAPAs, change controls, SOPs, and data integrity.

Responsibilities

• Serve as SME for microbiology testing and environmental monitoring.
• Lead method/equipment implementation, technical studies, investigations, and CAPA/Change Control activities.
• Provide technical direction to analysts and collaborate with multiple departments to resolve issues.

Skills

GMP compliance

Microbiology testing

Environmental monitoring

CAPA investigations

Change control

Cross-functional leadership

Regulatory inspections

Data integrity (ALCOA+)

Technical direction

Education

Bachelor's degree in Microbiology/Biology/Biochemistry

High School diploma or GED with GMP experience

Job description

MilliporeSigma is seeking a Senior Microbiologist to join the Quality Control Microbiology team in a GMP viral-vector manufacturing environment. You will lead microbiology testing and environmental monitoring efforts, implement methods and equipment, and drive technical studies and investigations.

You will provide direction to analysts and collaborate with Manufacturing, QA, Process Development, Engineering, Validation, and client teams to deliver compliant, reliable results, while supporting