Position SummaryThe Sr. Clinical Laboratory Associate (Sr. CLA) is an enthusiastic, self-motivated individual with great communication skills. Along with the duties described below, this individual leads and organizes efforts around sample receiving and accessioning, performance of routine preventive equipment and instrument maintenance, and provides assistance in the performance of high complexity laboratory testing on patient specimens under the direct supervision of a CLS. The Sr. CLA must demonstrate an exceptional level of individual accountability and possess the ability to perform the requirements listed below. The Sr. CLA must be comfortable in a rapidly evolving Biotech start-up environment.
Reports to: Sr. Manager, Clinical Laboratory Operations
Location: Redwood City, CA
Primary Responsibilities- Under supervision of licensed personnel, perform high complexity testing for commercial samples in accordance with applicable regulatory requirements and laboratory SOPs.
- For non-commercial or clinical study samples, perform routine molecular test procedures including specimen processing, nucleic acid extraction, quantitative analysis, PCR, library construction, sequencing, and data analysis.
- Support operational lab staff with sample receiving and accessioning per relevant
standard operating procedures (SOPs); serve as primary point of contact with the
customer support team to obtain information necessary to complete the accessioning
process.
- Prepare samples for processing in accordance with good laboratory practices and
established contamination control procedures.
- Operate high-throughput integrated automation workstations and utilize laboratory
information management systems (LIMS) and other infrastructure software in the
performance of job duties
- Coordinates directly with the procurement department to ensure reagents and
materials are available, qualified, and supplied to the laboratory for optimal
performance of daily workflow. Assists in ordering and identification of alternative
suppliers as necessary.
- Perform and document routine preventive maintenance for laboratory equipment and
instruments.
- Support regulatory compliance through adherence to laboratory policies and
procedures, and accurately document work performed.
Author and revise laboratory SOPs with minimal direction, ensuring applicable
regulatory requirements are reflected in controlled documents.
- Identify, escalate, and lead process improvement initiatives; monitor and report on
post-implementation performance.
- Supports the coordination of daily CLA activities under the direction of the Supervisor.
- Serve as point trainer for assigned processes and procedures; coordinate with
management to support competency assessments as appropriate.
- Perform additional duties as assigned by supervisory or laboratory leadership personnel.
What's Fun About the Job?Karius is operating at the edge of what is now known to be possible in diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.
Travel: No travel required.
Physical Requirements- Hours and days may vary depending on operational needs
- Standing or sitting for long periods of time may be necessary.
- May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation
- Manual dexterity as repetitive manual pipetting may be necessary
- Some lifting (up to 25 pounds) may be necessary
Position Requirements- Bachelor's degree in Biological science or similar field required.
- 5+ (five) years of clinical laboratory experience, with 4+ (four) years of pertinent industry experience and increasing levels of responsibility within a molecular biology laboratory
- Demonstrated ability to manage projects independently, or with minimal supervision.
- Prior experience with Next-Generation Sequencing (NGS) preferred.
- Knowledge of aseptic techniques used in a microbiology laboratory is highly preferred.
Personal Qualifications- Demonstrates personal accountability and ownership of assigned work and processes, consistently delivering results with quality, consistency, and attention to detail
- Proactively identifies, communicates, and escalates issues, risks, or deviations in a timely and transparent manner
- Adapts effectively to changing priorities and operational demands in a dynamic laboratory environment
- Demonstrates awareness of how individual responsibilities impact upstream and downstream laboratory operations
- Serves as a knowledgeable resource to peers, providing guidance and support to junior laboratory personnel
- Demonstrates curiosity and learning agility, seeking to understand laboratory processes beyond immediate scope and remaining open to feedback, coaching, and continuous skill development
- Maintains a collaborative, respectful, and team-oriented approach to daily operations
DisclaimerThe above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company, and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.