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: Bachelors' 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.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $81,200-$150,800/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$81,200.00 - $150,800.00

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence