Quality Assurance Specialist II

LOCATION: This opportunity is located at the Navigate BioPharma Services Carlsbad, CA site and will not have the ability to be located remotely.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Note: Other duties may be assigned.

• Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations.
• Support quality activities and provide quality oversight within the CLIA/biopharma laboratory to ensure
• compliance for clinical trial and nonclinical study specimen testing to GCP/GLP/GCLP requirements.
• Assist and/or conduct internal audits as assigned including ensuring completion of audit reports and audit responses.
• Assist with coordinating and supporting external audits/inspections.
• Assist in the monitoring of sub-contracted laboratories for compliance to regulatory and Navigate BP requirements.
• Assist in review of assay validations and reports.
• Assist in resolution of quality events, including preventive action.
• Assist with the performance of routine compliance checks.
• Assist in maintenance of appropriate CAP/CLIA, and state licenses for a CLIA medical laboratory and CAP and ISO accreditations.
• Contribute to development and monitoring of quality improvement initiatives and quality metrics
• Assist Quality Management in other activities as appropriate.

OTHER RESPONSIBILITIES

• Ensuring that Quality Events such as incidents and deviations are proper documented, and for supporting/owning the immediate remediation and preventative actions.
• Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed.
• Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions.
• Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed.

Minimum Requirements:

Education

• BS in engineering, medical technology, biological sciences, or related field.
• Clinical Laboratory Scientist (CLS) License

Years of Experience Required

• Minimum of five (5) years of related experience in a clinical lab or biopharma setting participating in audits and/or assay validations.

Required Skill Sets & Knowledge

• Strong organizational skills and detail oriented.
• Demonstrated knowledge of GxP, CLIA regulations and CAP guidelines is preferred.
• General familiarity with laboratory processes.  Knowledge of flow cytometry, cytogenetics and/or molecular techniques is preferred.

Languages:

• English

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

The pay range for this position at commencement of employment is expected to be between $92,800 and $139,200/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patient and communities we serve.
 

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network