JOB PURPOSE & IMPACT
Provide laboratory operations support by assisting the technical staff with equipment, instrument, and/or reagent qualification and other lab support duties. Perform tasks accurately and on schedule. Know and follow all safety procedures and be able to respond appropriately.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
• As assigned, assist in preventative maintenance, performance qualification and troubleshooting of instrumentation. Maintain inventory reports/logs according to established format/procedures.
• As assigned, assist in the performance of quality control procedures.
• As assigned, work in conjunction with external vendors and field service engineers to schedule instrument repair, relocation, and routine maintenance.
• As assigned, assist in implementation of new technologies and instrumentation.
• Document all quality control activities in accordance with laboratory requirements.
• Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.
• As assigned, prepare and store reagents, and maintain inventory reports/logs according to established processes.
• Identify issues related to equipment, instrumentation and/or reagents and immediately notify the general supervisor, technical supervisor, or director.
• Assists with Lab QA metrics and reporting.
• Follow the laboratory's procedures for specimen labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens.
• Assist in the performance of quality control procedures.
• May participate in training of new employees as assigned.
• As assigned, provide departmental support such as identification and retrieval of instrument and quality data, writing work instructions and performance qualification reports, copying, filing, data entry, and additional duties as needed.
• 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
EEO Statement The Novartis Group of Companies 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.
Minimum requirements MINIMUM EDUCATION, EXPERIENCE, SKILLS
Note: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Bachelor’s degree in biology, biochemistry, molecular biology or related field required. Combination of experience and education may be considered in lieu of a degree.
Years of Experience Required
• Two (2) years’ experience working in a regulated laboratory or a clinical lab setting strongly desired
Required Skill Sets & Knowledge
• Excellent verbal communication skills for working with co-workers, external vendors, and all levels of laboratory staff. Meticulous attention to detail. Demonstration of solid reasoning skills in experimental design, data analysis and interpretation. Excellent organizational and time management skills. Laboratory QC experience desirable. Demonstrated knowledge of, and ability to follow established laboratory procedures for the use of mechanical or electronic instruments.
Note: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
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 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
Note: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to laboratory instruments.
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.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Business Unit NAVIGATE BIOPHARMA SERVICES
Site Carlsbad, CA
Company/Legal Entity Navigate BioPharma Svcs., Inc.
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Shift Work No