Laguna Source · 4 days ago
Quality Control Microbiologist, Expat in South Korea
LA Metro Area
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expLaguna Source is a leading company in biopharmaceutical manufacturing, seeking a Quality Control Microbiologist. This role involves leading QC microbiology activities, developing monitoring programs, and ensuring compliance with regulatory standards.
BiotechnologyHealth CareHuman ResourcesRecruiting
Hiring Manager
Jeff Schwartzman
Responsibilities
Design, implement, and validate environmental and utility monitoring programs aligned with global regulatory standards (FDA, EMA, USP, EP, JP)
Establish sampling procedures and select monitoring points based on risk assessments, facility design, and product requirements
Interpret microbiological data using statistical tools and recommend improvements
Serve as the site’s SME for contamination control strategy and aseptic best practices
Provide input on facility design, material/personnel flow, and contamination risk mitigation
Establish robust contamination prevention procedures for manufacturing processes
Perform microbial identification testing and lead microbiological deviation investigations (e.g., OOS, OOT, OAL)
Support risk assessments of raw materials, intermediates, and finished products
Establish and refine microbiological QC testing practices and protocols
Collaborate with QA, Manufacturing, Validation, and Engineering teams to ensure QC readiness
Guide the implementation of microbiological standards across the organization
Ensure alignment with cGMP and international microbiology regulations
Represent microbiology programs during internal and external audits
Develop and maintain microbiology-related SOPs, validation protocols, and reports
Develop and conduct microbiology training for cross-functional teams
Drive knowledge-sharing of microbiology best practices and compliance expectations
Evaluate and implement advanced microbiological testing technologies and methods
Monitor emerging trends and regulatory expectations to future-proof contamination control practices
Qualification
Required
Bachelor's, Master's, or Ph.D. in Microbiology, Biology, Biochemistry, or related life sciences field
10+ years of experience in a GMP-regulated biopharma environment with emphasis on QC microbiology and contamination control
Proven track record in developing and implementing EM programs and microbiological quality systems
In-depth knowledge of microbiology-related regulatory standards (USP, EP, JP, FDA, EMA)
Familiarity with risk assessment tools and microbiological statistical data interpretation
Excellent cross-functional communication and leadership skills
Preferred
Experience in facility startup, tech transfer, or commissioning & qualification highly desirable
Benefits
Company paid apartment
International school tuition
Relocation assistance
Competitive base salary
Target bonus
Retirement allowance
Excellent medical benefits
Company paid luxury apartment in Songdo
International school tuition paid for children at the top rate Chadwick International School in Songdo
Company paid airfares to visit the US (or country of origin)
3-4 weeks of vacation time
Company
Laguna Source
Laguna Source provides recruitment, placement, and job search service for the bioPharma, life sciences, IT, and medical industries.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Jeff Schwartzman
Recruiter/Managing Partner within Life Sciences and Food & Nutrition Industries
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