Overview
QC Microbiologist Jobs in Carlsbad, California, USA at Kappaalphapsi1911
Job Description Summary
The QC Microbiologist supports all technical aspects related to quality control testing readiness, including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing, and documentation completion and review in full compliance with GMP regulation, procedures, and product specifications.
Location: Carlsbad, CA #LI-Onsite
This position may involve shift work which will be defined through site start up and commercialization readiness. On-call work may also be required.
Job Description
Key accountabilities:
Finished Product testing, Environmental Monitoring and Sterility QC testing, and reporting of the QC results.
Escalation in case of non-conformances and deviations and manage these quality incidents as per AAA procedures.
Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow up and implementation, and Change Control management, including procedure and form revisions.
Participation in assigned qualification/validation activities, as necessary.
Responsible for successful on-time completion of required training curricula comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications, and other relevant training including HSE for the specific role.
Prepares applicable documents, forms, and records such as analytical batch records and follows Good Documentation Practices.
Support internal and external Audits and Inspections, as required.
Essential Requirements:
Education:
Bachelor’s degree preferred in relevant Scientific discipline (e.g Chemistry, Microbiology). In lieu of degree, 3 years of prior experience in a similar QC role within cGMP will be considered.
Minimum of 3-year experience in cGMP or aseptic environment required.
Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for product and Environmental Monitoring testing, as well as Aseptic techniques.
Practical experience with Microbiology method verification and routine testing practices, EM Monitoring and basic knowledge of method/equipment validation principle and methodologies.
Ability to interpret analytical data and convert into technical documentation.
Basic knowledge and understanding of aseptic principles and techniques.
EEO Statement:
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.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonab or call  and let us know the nature of your request and your contact information.
Please include the job requisition number in your message.
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Title: QC Microbiologist
Company: Kappaalphapsi1911
Location: Carlsbad, California, USA
Category: Quality Assurance – QA/QC (Data Analyst), Healthcare (Data Scientist)
