QC Microbiologist
QC Microbiologist
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$ 81200 - 150800
1 Vacancy
Job Description
Band
Level 3Job 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
Shift: Wednesday to Saturday 12 hour shifts; however shift will be defined through site start up and commercialization readiness. Apply only if you are available for weekends and off shifts.
Job Description
Key Responsibilities:
- 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 required in relevant Scientific discipline (e.g Chemistry Microbiology) strongly lieu of a degree 3-5 years of relevant experience in similar role in Pharma/Manufacturing sector in analytical lab may be considered.
- Minimum of 3 years of 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 salary for this position is expected to range between $81200 and $150800/year. The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.
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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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 in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Continued Learning Dealing With Ambiguity Decision Making Skills Gxp Industry Standards Laboratory Equipment Laboratory Excellence Quality Control (Qc) Testing Quality Control Sampling Self-Awareness Technological Expertise Total Quality ManagementEmployment Type
Full-Time
