JOB SUMMARY
Responsible for performing high complexity laboratory testing on clinical specimens, interpreting and reporting results and complying with study protocols, Standard Operating Procedures, Test Instructions, and related CAP/CLIA Regulations and guidelines. Participates in scientific studies and activities supporting registrational and non-registrational clinical trials. Receives general instructions; plans and executes own work.
Responsibilities
• Works under general supervision, to support aspects of clinical testing and sample processing, adhering to CAP/CLIA regulations and ISO 15189 guidelines.
• Performs high-complexity testing within the CDx CAP/CLIA Laboratory. Monitors performance of IHC, ISH, molecular assays, and immunoassays; assists with lab failure investigations and root cause analysis.
• Performs accessioning of biological samples (blood, plasma, tissue) and quality control of demographic data input. Communicates with clients on held and rejected samples.
• Performs work according to established internal safety guidelines and procedures, and as specified by appropriate regulatory agencies (SHE, OSHA)
• Critically evaluated quality control and test results against acceptance criteria to support clinical testing.
• Uses technical writing skills and Good Documentation Practices to complete lab documentation, SOPs, and Quality documents.
• Participate in routine lab maintenance and lab safety inspections.
• May perform basic troubleshooting for issues related to instrumentation.
• Analyzes alternative approaches to solve problems or develop new perspectives on existing solutions; initiate and implement process improvements.
• Other duties as assigned by management.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
Formal Training/Education
Bachelor's Degree Must possess a BS or BA degree in a related discipline
Experience
1 year experience working in a clinical laboratory
Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), histology lab experience (CAP/CLIA), immunoassays and molecular biology experience.
Knowledge, Skills and Abilities
• Demonstrated proficiency in computer skills, such as word processing, statistical analysis, and
• laboratory information systems.
• Excellent verbal and written communication skills.
• Strong understanding of good laboratory practices and regulatory compliance.
• Requires excellent attention to detail; ability to multi-task and be flexible with tasks and schedules.
Travel Requirements
As needed Based on business needs
Shift: Flexible for shifts outside of regular working hours (8am-5pm) as well as regular Mon-Fri working days.
This is the pay range that Magnit reasonably expects to pay for this position: $27.00/hour-$30.00/hour
Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met)
Magnit has an ongoing commitment to the diversity and inclusion of all team members. We believe that embracing diversity leads to innovation and helps address the needs of the business. We welcome individuals from different backgrounds, experiences, and cultures to join our team. We value this diversity and strive to create an inclusive environment that celebrates these unique perspectives, allowing you to contribute to your full potential. Finally, but most importantly, we expect all team members to be treated with dignity and respect.
If you have a disability and need an accommodation in relation to the online application process, please email us at Roche.Accommodations@magnitglobal.com