POSITION SUMMARY:

Execute test methods to evaluate quality, functionality, and stability of Personalized Cancer Monitoring (PCM) finished products to ensure that they are in compliance with specifications. Track and identify trends in sample data and recommend corrective actions when necessary. Assist project teams with method transfer, method validation and method troubleshooting activities. Conduct out-of-specification (OOS)/ out-of-trend (OOT) investigations as needed. Lead and support process improvement projects within the manufacturing and QC laboratory. This position will cross-train in the RUO (Research Use Only) and IVD (In-Vitro Diagnostics) manufacturing and QC laboratories and will serve as a liaison between manufacturing and QC.

RESPONSIBILITIES:

• Complete testing for PCM finished products to determine conformance to specifications
• Support development of sample preparation methodology and testing methodology
• Author, review, and approve controlled procedures in support of QC process steps
• Perform critical analysis of testing results, ensuring compliance with standards and specifications
• Generate test results reports and product conformance documentation
• Adhere to safety and quality standards
• Complete and maintain personal training and associated records
• Maintain laboratory material inventory and initiate replenishment requests as required
• Execute test method validation and product stability testing protocols
• Identify non-conforming material and generate requisite reports (OOS/OOT investigation)
• Review, understand, and comply with ArcherDX HIPAA Security policies and procedures

KEY ATTRIBUTES:

• Drive and determination
• Ability to work in a fast-paced and dynamic environment
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company
• Strong communication and presentation skills
• Self-starter
• Self-directed: needs little explicit direction
• Able to organize, prioritize, and delegate tasks to efficiently move projects forward.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in a science-related field
• 3 or more years of experience in a GMP laboratory setting 
• Experience utilizing micro-pipettes 

PREFERRED QUALIFICATIONS:

• Prior experience with oligonucleotides
• Hands-on experience with PCR and genetic sequencing 
• Prior experience with automated sample preparation equipment, such as Tecan or Hamilton liquid handling units