Novartis
Overview
QC Microbiologist role at Novartis. The position supports all technical aspects related to quality control testing readiness, including QC reagents and materials management, equipment preparation and daily cleaning and maintenance, sample management and QC testing, and documentation completion and review in full compliance with GMP regulation, procedures, and product specifications. About the Role
Location: Carlsbad, CA Shift: Wednesday to Saturday, 12 hour shifts; shift may be defined through site startup and commercialization readiness. Applicants must be available for weekends and off shifts. Key Responsibilities
Perform Finished Product testing, Environmental Monitoring and Sterility QC testing, and report QC results. Escalate non-conformances and deviations and manage quality incidents per AAA procedures. Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow-up and implementation, and Change Control management, including procedure and form revisions. Participate in assigned qualification/validation activities as necessary. Ensure timely completion of required training curricula covering SOPs, Aseptic Techniques, Gowning Qualifications, Testing and specifications, and other role-specific training including HSE. Prepare relevant documents, forms, and records such as analytical batch records in accordance with Good Documentation Practices. Support internal and external audits and inspections as required. Essential Requirements
Education: Bachelor's degree in a relevant scientific discipline (e.g., Chemistry, Microbiology) preferred. In lieu of a degree, 3–5 years of relevant pharma/manufacturing analytical lab experience may be considered. Minimum 3 years of experience in a cGMP or aseptic environment. Knowledge of cGMP regulations and FDA guidance for QC and Environmental Monitoring testing; understanding of aseptic techniques. Practical experience with microbiology methods verification and routine testing; EM monitoring; basic knowledge of method/equipment validation principles and methodologies. Ability to interpret analytical data and convert into technical documentation. Basic knowledge and understanding of aseptic principles and techniques. Compensation and Benefits
The salary for this position is expected to range between $81,200 and $150,800 per year. Final salary offered will reflect skills and experience; compensation may include a performance-based cash incentive and eligibility for annual equity awards. US-based eligible employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, generous time off, and other leaves and perks. Why Novartis
Novartis emphasizes collaboration, support, and breakthroughs to change patients’ lives. Learn more about the company culture and opportunities at Novartis. EEO and Accessibility
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to providing reasonable accommodations in the application process and to perform essential functions of the position; please contact us with your request and the job requisition number.
#J-18808-Ljbffr
QC Microbiologist role at Novartis. The position supports all technical aspects related to quality control testing readiness, including QC reagents and materials management, equipment preparation and daily cleaning and maintenance, sample management and QC testing, and documentation completion and review in full compliance with GMP regulation, procedures, and product specifications. About the Role
Location: Carlsbad, CA Shift: Wednesday to Saturday, 12 hour shifts; shift may be defined through site startup and commercialization readiness. Applicants must be available for weekends and off shifts. Key Responsibilities
Perform Finished Product testing, Environmental Monitoring and Sterility QC testing, and report QC results. Escalate non-conformances and deviations and manage quality incidents per AAA procedures. Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow-up and implementation, and Change Control management, including procedure and form revisions. Participate in assigned qualification/validation activities as necessary. Ensure timely completion of required training curricula covering SOPs, Aseptic Techniques, Gowning Qualifications, Testing and specifications, and other role-specific training including HSE. Prepare relevant documents, forms, and records such as analytical batch records in accordance with Good Documentation Practices. Support internal and external audits and inspections as required. Essential Requirements
Education: Bachelor's degree in a relevant scientific discipline (e.g., Chemistry, Microbiology) preferred. In lieu of a degree, 3–5 years of relevant pharma/manufacturing analytical lab experience may be considered. Minimum 3 years of experience in a cGMP or aseptic environment. Knowledge of cGMP regulations and FDA guidance for QC and Environmental Monitoring testing; understanding of aseptic techniques. Practical experience with microbiology methods verification and routine testing; EM monitoring; basic knowledge of method/equipment validation principles and methodologies. Ability to interpret analytical data and convert into technical documentation. Basic knowledge and understanding of aseptic principles and techniques. Compensation and Benefits
The salary for this position is expected to range between $81,200 and $150,800 per year. Final salary offered will reflect skills and experience; compensation may include a performance-based cash incentive and eligibility for annual equity awards. US-based eligible employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, generous time off, and other leaves and perks. Why Novartis
Novartis emphasizes collaboration, support, and breakthroughs to change patients’ lives. Learn more about the company culture and opportunities at Novartis. EEO and Accessibility
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to providing reasonable accommodations in the application process and to perform essential functions of the position; please contact us with your request and the job requisition number.
#J-18808-Ljbffr