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In Lims Validation Jobs in California (NOW HIRING)

Heluna Health

Microbiologist I (MDL)

Richmond, CA · On-site

$33.27/hr

... LIMS), and applies good safety practices in the workplace. Some functions performed by the ... Assists with development, validation, and implementation of new and/or improved procedures, such as ...

Heluna Health

Microbiologist I (MDL)

Richmond, CA

$33.27/hr

... LIMS), and applies good safety practices in the workplace. Some functions performed by the ... Assists with development, validation, and implementation of new and/or improved procedures, such as ...

Natera

Associate Scientist, R&D

San Carlos, CA · On-site

$50 - $57/hr

... validation activities. You will engage deeply in the scientific process, conduct meticulous ... in LIMS, database queries for accurate tracking and verification * Conduct independent ...

Syensqo

Laboratory Technical Lead

Anaheim, CA · On-site

... valid, accurate, and complete prior to release (including correct units, significant figures, outlier handling per procedure, and required attachments). * Approve/release results in LIMS (or ...

Syensqo

Laboratory Technical Lead

Anaheim, CA · On-site

... valid, accurate, and complete prior to release (including correct units, significant figures, outlier handling per procedure, and required attachments). * Approve/release results in LIMS (or ...

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All JobsIn Lims Validation JobsIn Lims Validation Jobs in California

In Lims Validation information

What is the difference between In Lims Validation vs Laboratory Technician?

AspectIn Lims ValidationLaboratory Technician
CertificationsGMP, GLP, Validation certificationsTypically relevant certifications include Lab Technician or related training
Work EnvironmentQuality assurance, validation labs, regulated industriesLaboratories performing tests and experiments
Job FocusEnsuring LIMS systems meet regulatory standardsPerforming tests, recording data, maintaining lab equipment

In Lims Validation professionals focus on validating Laboratory Information Management Systems to ensure compliance with industry standards, while Laboratory Technicians perform routine testing and data collection. Both roles are essential in regulated labs but differ in scope and responsibilities.

How to validate a LIMS system?

Validating a LIMS (Laboratory Information Management System) involves developing a validation plan, performing installation and operational qualification, and documenting each phase to ensure the system meets user requirements and regulatory standards. It typically includes testing data integrity, system security, and functionality, often supported by validation protocols and traceability. Familiarity with regulatory guidelines such as 21 CFR Part 11 is essential for compliance.

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In Lims Validation jobs near you

Microbiologist I (MDL)

Heluna Health

Richmond, CA • On-site

$33.27/hr

Part-time

Posted 7 days ago

Job description

The California Department of Public Health's (CDPH) Microbial Diseases Laboratory (MDL) Branch is responsible for diagnostic and surveillance testing, applied research projects, and education and training for the identification and characterization of bacterial, mycobacterial, fungal, and parasitic pathogens of public health importance.
The Microbiologist I works within the Mycobacterial Drug Susceptibility Testing Unit of the Mycobacterial, Mycotic & Parasitic Diseases Section of the Microbial Diseases Laboratory Branch, under the direct supervision of the Research Scientist Supervisor I.
Under direct supervision, the Microbiologist I performs duties associated with sample receipt, processing, culture, identification, and drug susceptibility testing of Mycobacterium tuberculosis. The Microbiologist performs quality control (QC) and follows quality assurance (QA) procedures, uses the MDL Laboratory Information Management System (LIMS), and applies good safety practices in the workplace. Some functions performed by the Microbiologist I will be conducted under Biosafety Level 3 conditions, requiring the use of appropriate respiratory protection. The candidate is expected to have basic laboratory knowledge and skills in order to perform the duties of this position, including, but not limited to: culture inoculation, ability to use a pipette, demonstration of good aseptic technique, knowledge and understanding of basic operation of general laboratory equipment (e.g. incubators, freezers, autoclave), and demonstration of safe laboratory practices when handling infectious and/or hazardous materials.
Must submit a resume with the application to be considered. Please provide three professional references.
The salary range is $33.27 - $49.02 depending on experience and qualifications.
This is a part-time, on-site position, with flexible hours during normal business hours, Monday through Friday. Depending on the workload, 8-16 hours per week are expected. Work on weekends, holidays, and overtime coverage may be offered during a public health emergency, but it is not required.
If hired for this position, you will be required to provide proof that you are fully vaccinated for COVID-19 prior to your start date or have a valid religious or medical reason qualifying you for an exemption (that may or may not require an accommodation).
ESSENTIAL FUNCTIONS
  • Serves as a bench-level microbiologist for drug susceptibility testing of mycobacterial pathogens (e.g. Mycobacterium tuberculosis) using various platforms, including the BACTEC MGIT 960 and ThermoFisher Sensititre.
  • Perform duties associated with sample receipt and accessioning.
  • Performs identification using conventional culture, microscopic, and molecular methods (e.g. sequencing, real-time PCR).
  • Interprets, records, and reports test results to submitters in a timely manner.
  • Performs testing for and reports on proficiency testing specimens.
  • Accurately and thoroughly records and documents test results and quality control data following standard operating procedures.
  • Reviews test results for completeness and accuracy.
  • Communicate professionally with colleagues, supervisors, and internal/external clients.
  • Maintains inventory of essential chemicals, reagents, and disposables.
  • Performs quality control, maintenance, and quality assurance procedures to ensure optimal performance of tests and to fulfill Clinical Laboratory Improvement Amendments (CLIA) regulations and MDL QA policies.
  • Performs all work in compliance with MDL, Section, and Unit policies for laboratory operations including biosafety, chemical hygiene, quality, and other applicable standards.
  • Prepares and orders laboratory reagents and media for testing and research purposes.
  • Uses the Laboratory Information Management System (LIMS) for test tracking and reporting.
  • Updates laboratory SOPs and other laboratory aids and forms as directed.
  • Assists with development, validation, and implementation of new and/or improved procedures, such as, but not limited to, new and/or improved testing assays and methodologies for the identification and characterization of microorganisms, data entry and reporting processes in LIMS, and streamlined QA/QC tasks.
  • Performs other applicable duties as assigned, including assisting other units or sections as needed for surge capacity.

JOB QUALIFICATIONS
  • Ability to perform micromanipulations such as pipetting small volumes and other fine measurements using laboratory instrumentation and equipment.
  • Experience working with microbial pathogens, preferably in a clinical or public health microbiology laboratory setting
  • Experience with routine culture and molecular methods.
  • Knowledge of sterile technique and universal precautions for working with bacterial pathogens.
  • Demonstrated attention to detail.

EDUCATION/EXPERIENCE
  • Possession of a bachelor's degree in microbiology or related biological science from an accredited university.
  • Minimum of two years of experience handling infectious agents in a microbiology laboratory setting; preferably in a clinical or public health laboratory performing high complexity testing.

Certificates/Licenses/Clearances
Possession of a current Public Health Microbiologist (PHM) Certificate. Applicants who do not possess the required California PHM certificate but are eligible for the examination for certification may apply and be approved for employment. Public Health Microbiologist Certification within 6 months of appointment is required.
Other Skills, Knowledge, and Abilities
  • Computer skills (Microsoft Word, Excel, email)
  • Ability to effectively communicate verbally and in writing.
  • Ability to work independently and adapt to varied work settings.
  • Ability to work effectively with a team of diverse individuals.
  • Ability to maintain regular in-person attendance.
  • Ability to perform tasks in a timely manner and respond to urgent requests.
  • Ability to follow written and verbal instructions.

PHYSICAL DEMANDS
  • Stand Frequently
  • Walk Frequently
  • Sit Frequently
  • Handling / Fingering Frequently
  • Reach Outward Occasionally
  • Reach Above Shoulder Occasionally
  • Climb, Crawl, Kneel, Bend Occasionally
  • Lift / Carry Occasionally - Up to 25 lbs.
  • Push/Pull Occasionally - Up to 25 lbs.
  • See Constantly
  • Hear Frequently
  • Taste/ Smell Not Applicable

KEY
Not Applicable Not required for essential functions
Occasionally (0 - 2 hrs/day)
Frequently (2 - 5 hrs/day)
Constantly (5+ hrs/day)
WORK ENVIRONMENT
Laboratory setting, indoor and airflow and temperature controlled.
Vaccinations (recommended, not required). Work in a BSL-3 environment is required.
EEOC STATEMENT
It is the policy of Heluna Health to provide equal employment opportunities to all employees and applicants, without regard to age (40 and over), national origin or ancestry, race, color, religion, sex, gender, sexual orientation, pregnancy or perceived pregnancy, reproductive health decision making, physical or mental disability, medical condition (including cancer or a record or history of cancer), AIDS or HIV, genetic information or characteristics, veteran status or military service.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.

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