QA Systems Compliance Specialist
Location
Carlsbad, CA | United States
Job description
About the Role
Location: Carlsbad, CA
About the Role:
This position is a member of the Quality department and has direct responsibility for Quality review and release of systems (software, equipment, instrumentation, utilities) used at Navigate in support of GxP functions including IVD and CLIA activities. The position provides Quality oversight and approval in partnership with business functions ensuring systems are appropriately qualified and validated for intended use and supporting the lifecycle of systems (onboarding, maintenance, change, periodic review, and retirement). The position requires an associate who can present Navigate’s compliance program along with executed project documents and records during external inspections/audits. The position will support continuous improvement through the development of training, guidance documents and templates.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Responsible for systems compliance to US GxP and EU regulations for GxP, IVD, and CLIA activities
• Responsible for computer system validations (CSV) along with lab equipment systems to ensure compliance with GxP and CLIA
• Provide input for the design, implementation and validation of new systems or change to existing
• Provide Quality oversight, review, and approval for regulated systems including validation, maintenance, change control, and incident records
• Review and approve records for regulated systems
• Prepare and maintain site audit readiness and present process and records during regulatory and sponsor inspections
• Represent Quality in IVD Design Control activities and product release
• As a member of the Quality Department, support other departmental activities as assigned.
• Work in a GxP/CLIA regulated environment and is responsible for following all applicable regulations
ADDITIONAL 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
Diversity & Inclusion / EEO
We are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 are committed to building diverse teams, representative of the patients and communities we serve, and 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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail [email protected] or call +1 (877)395-2339
- Sandoz: e-mail [email protected] or call: +1-609-422-4098
Role Requirements
QUALIFICATIONS:
This opportunity is located at the Navigate BioPharma Services Carlsbad, CA site and will not have the ability to be located remotely
Experience & Requirements:
• BS in engineering, medical technology, biological sciences, or related field
• Minimum of five (5) years direct experience working in a Quality role in a GxP regulated environment overseeing laboratory instrumentation and computerized systems
• Strong communication, collaboration, and presentation skills
• Ability to give clear guidance to internal customers
• Working knowledge of the FDA and regulatory principles for IVDs and EU IVDRs
• Experience with GxP laboratory compliance requirements for computerized systems, laboratory equipment and 21CFR Part 11
• Experience with ISO 13485, ISO 15189 is a plus
• Technical writing as it relates to generating validation documents, templates, and SOPs or Work Instructions
• Understanding of risk-based practices in a GxP testing laboratory
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus
WORK ENVIRONMENT:
While performing the duties of this job, the employee is occasionally exposed to laboratory / manufacturing, facility instruments and utilities
The work environment involves moderate exposure to unusual elements including extreme temperatures, fumes, smoke, unpleasant odors, and/or loud noises. The work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and includes the use of protective equipment. The noise level in the work environment is usually moderate. Interaction with laboratory equipment, samples, supplies, and laboratory personnel may be required whereby appropriate precautions are to be taken per the Company’s Safety and Injury, Illness and Prevention Plans
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: People and Culture | Novartis.
Pay transparency statement: The pay range for this position at commencement of employment is expected to be between $85,920 and $126,000/per annum; 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.
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