Descrizione:
QC Microbiological Laboratory Supervisor
As QC Microbiological Laboratory Supervisor, you will lead the microbiological QC lab to ensure compliant, on-time testing and high-quality results. You’ll provide technical leadership across operations supporting pharma manufacturing and release, while driving audits, CAPAs, and continuous improvement. You will mentor the team, optimize workflows, and partner with cross-functional groups to uphold safety and quality. This role offers impact across regulatory compliance, product quality, and customer satisfaction in a global setting.
Lead and coordinate microbiological QC testing in compliance with safety regs, approved methods, and GMP standards
Provide technical oversight of lab operations from raw material testing to finished product release and stability studies
Support audits and inspections by coordinating cross-functional activities and ensuring timely documentation
Draft and review specifications, study protocols, analytical methods, and SOPs per GMP and quality standards
Participate in customer meetings to discuss technical topics within microbiology
Lead investigations of OOS/OOT, and implement CAPAs
Oversee Method Development, Validation, and Transfer activities for projects
Collaborate on department budget and CAPEX; optimize lab operations
Drive operational excellence through Lean and PPI, mentoring, and process improvements
Lead, coach, and develop the team with clear objectives and performance management
Bachelor's degree or higher in Biology, Microbiology, Biochemistry, Pharmaceutical Chemistry and Technology (CTF), or related scientific discipline
Several years of experience in Microbiological Quality Control in pharma/biotech
At least 3 years in a people leadership role managing laboratory operations
Experience in pharmaceutical manufacturing, preferably aseptic environment
Strong knowledge of cGMP, FDA, EU GMP, ICH, and pharmaceutical quality systems
Knowledge of Quality Risk Management, risk assessment, and Root Cause Analysis
Understanding of ALCOA+ Data Integrity principles and regulatory expectations
Excellent technical writing skills for SOPs, investigations, methods, protocols, and regulatory docs
Strong leadership, problem-solving, and team management skills
Excellent interpersonal and communication skills; ability to engage stakeholders across levels
Ability to manage conflicting priorities in a dynamic team
Proficiency with Microsoft Office, LIMS, and eQMS
Professional certifications in Quality Systems, Regulatory Compliance, Lean Six Sigma, or Project Management are advantageous
As QC Microbiological Laboratory Supervisor, you will lead the microbiological QC lab to ensure compliant, on-time testing and high-quality …
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