Quality Control Scientist I

2 weeks ago

San Diego, United States Truvian Sciences Full time
Job DescriptionJob DescriptionABOUT
Truvian is not just a healthcare company but a pioneer at the intersection of diagnostics and consumer tech. We aim to revolutionize blood testing by developing an automated benchtop diagnostic system that provides lab-accurate results in 30 minutes or less. This innovative approach, for which we are seeking FDA clearance, is set to transform the healthcare industry by making blood testing accessible and affordable from one small blood sample in minutes in a retail setting or private clinic.

At Truvian, we don't just have jobs; we have a mission. We are a culture dedicated to discovery and empowerment, striving to put health information where it belongs—in the hands of the individual. We believe that talented people working as a team can turn every day into an adventure. Join us in our mission to make routine health testing convenient, affordable, and actionable for today’s connected consumers

JOB SUMMARY
We seek a talented Quality Control Scientist I to join our quality team. As the QC Scientist I, you will have a solid analytical and compliance background, with proven troubleshooting skills in bulk reagents and consumables for Truvian’s IVD product while maintaining cGMP standards. This position requires a close relationship with QA, product development, and manufacturing. It will report to the QC Supervisor. 

The nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules, and the ability to work independently in a cross-functional team environment.

HERE’S WHY YOU’LL LOVE THIS JOB:
  • You will be integral in launching the first core product for Truvian, which is a game changer
  • You'll work with a rock-star team of people who are passionate about the work they do and our ability to disrupt healthcare with our innovative products
  • You’ll be a key player on a team responsible for the company’s growth and product launch
  • You thrive in a fast-paced and dynamic environment where you can implement fresh ideas and new processes and make things happen quickly without a bunch of tapes
  • You’ll have great perks such as Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), paid parental leave, flexible vacation time off, Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks, on-site gym, and virtual classes, and a farm to table onsite restaurant including a 30% discount


WHAT YOU WILL DO:
You will lead the quality control team and be integral to launching readiness for the integrated consumable utilized within Truvian’s blood analysis system.

This will require the following:
  • Your involvement in the method development, verification, and validation is critical to this role. 
  • The role will be to analyze lot release and stability samples for a product in its clinical phase.
  • Author and review QC analytical SOPs, protocols, and reports as needed.
  • Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports
  • Participate in establishing sample plans, managing in-process, and releasing test samples.
  • Maintained QC laboratory, tracked critical reagents and equipment logbooks, and ensured all the equipment is calibrated.
  • Document, investigate, and implement corrective actions regarding all the QC issues using CAPA or NCMR/MCR processes as needed.
  • Effectively communicate technical information to a technical and non-technical audience

 WHAT YOU WILL BRING:

  • Bachelor's degree in scientific discipline with a minimum of 10+ years’ experience in IVD or Master’s Degree with 3+ years’ experience; or a PhD with 2 years of experience

  • Must have prior experience in quality control for in vitro diagnostic devices in a regulated environment
  • Experience in clinical chemistry, immunoassays, and hematology assays’ quality control
  • Demonstrated technical writing skillset
  • Experience with design control, verification and validation studies, and regulatory submissions are strongly desired
  • Familiarity with quality management systems (e.g., Arena, MasterControl) and project tracking software (Smartsheet, Jira) is a plus
  • Understanding the requirements for working in a GMP, GLP, ISO-certified, or FDA workplace as they apply to manufacturing
  • Solid analytical and problem-solving skills; extremely detail-oriented, organized, self-starter, self-motivated, and independent problem-solver
  • Able to work with cross-functional teams
  • Proven interpersonal, communication, and presentation skills
  • Able to excel in a collaborative, fast-paced, and evolving start-up environment; able to manage competing priorities
  • Ability to proactively identify issues and address them with a solutions-oriented approach
  • Excellent verbal and written communication skills. Must be able to communicate verbally efficiently and effectively and be proficient in written documentation and technical presentations
  • Demonstrated leadership skills, including organization and prioritization of complex activities, effectiveness in providing technical direction to others, and quantitative delivery of team objectives
  • Excellent time management skills with a proven ability to meet deadlines
  • Able to excel in a collaborative, fast-paced, and evolving start-up environment; able to manage competing priorities
  • Attention to detail; produces work of exceptional quality and accuracy

SALARY RANGE
$89,280 to $100,000 Annually

This range considers the factors considered in making compensation decisions, including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs.  Salary offers are determined based on the final candidate's qualifications and experience.  Placement within the compensation range is determined by internal equity and relevant qualifications.

SUPERVISORY ROLE 
  • No

PHYSICAL DEMANDS AND ABILITIES 
  • Regularly required to use hands to finger, handle, or feel, reach with hands and arms, and talk or hear
  • Ability to lift and move 5 lbs. repeatedly and safely
  • Frequently required to stand, walk, stoop, kneel,
  • Occasionally required to sit and climb or balance
  • Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus

If you want to stand out, please include a cover letter

Truvian provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

 

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