TakedaPharmaceutical Nordics AB ยท 10 hours ago
QC Specialist III - Microbiology
Los Angeles, CA
Full-time
Onsite
Mid Level
$86K/yr - $136K/yr
3+ years expTakeda Pharmaceutical Nordics AB is committed to transforming patient care through the development of novel specialty pharmaceuticals. The QC Specialist III - Microbiology will conduct advanced microbiological research and testing, ensuring compliance with regulatory standards while leading continuous improvement projects in QC Microbiology.
Pharmaceuticals
Responsibilities
Identify and drive continuous improvement projects to improve quality, service, reliability, delivery, and/or cost by enhancing microbiological testing and laboratory operations
Lead and provide project support for QC Microbiology, including microbiological assay validation, laboratory equipment qualification, and method improvement studies
Understand operations/processes to provide technical support to troubleshoot and resolve issues related to microbiological assays, instruments, and equipment
Author technical documents, protocols, and reports related to lab equipment qualifications, assay validations, and compliance-related studies as needed
Maintain and compile QC Microbiology metrics including trend reports as needed (e.g., environmental monitoring)
Perform or review gap assessments for QC Microbiology to align with Global standards and regulatory requirements
Maintain applicable QC Microbiology Standard Operating Procedures (SOP) to ensure compliance with FDA guidelines, QSR, cGMP, and other regulatory standards and drive procedural improvements
Support internal and external audits (e.g., FDA, Corporate Quality Assessments) by ensuring compliance with procedures, guidelines, and regulatory requirements
Serve as a subject matter expert and point of contact during inspections, providing responses to inquiries and demonstrating compliance with regulatory requirements
Provide technical training and presentations to QC laboratory staff, including management, to ensure understanding of microbiological testing procedures and compliance
Lead or actively contribute to team initiatives that enhance efficiency, cost savings, quality improvements, and problem-solving
Proactively identify training needs, ensure personal training requirements are met, and maintain training records for laboratory personnel
Stay current in the technical and compliance fields related to lab instruments, microbiological methods, and industry best practices
May perform other duties as assigned
Qualification
Required
Typically requires bachelor's degree in science, engineering or other related technical field
3+ years of related experience
Strong knowledge of cGMP, QSR, USP, CFR, and other regulatory requirements
Demonstrated working knowledge of microbiological assays, instrumentation, and equipment
Ability to manage multiple priorities, meet deadlines, and maintain high-quality standards
Strong organizational and problem-solving skills, with the ability to recommend and implement technical solutions
Proficient in Microsoft Office (Word, Excel) and other relevant digital tools
Detail-oriented, accountable, and committed to quality and compliance
Skilled in decision-making to address technical, compliance, or operational issues; supports cross-functional problem-solving initiatives
Solid understanding of laboratory, manufacturing, and facility processes
Excellent verbal and written communication skills; able to collaborate effectively and train peers
Working knowledge of applicable SOPs, EHS requirements, and cGMP/GDP standards
Preferred
Bachelor's Degree in Chemistry or Biological Science
Benefits
U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Company
TakedaPharmaceutical Nordics AB
Takeda Pharma AB is engaged in sales marketing For USA
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase