Job description

RESPONSIBILITIES:

• Adhere to all Q Squared Solutions policies, procedures and employee handbook contents.
• Introduce and drive implementation of new technologies to improve processes for departmental and business unit objectives.
• Development and validation of molecular assays using custom or bespoke automated solutions.
• Interface directly with team members and internal clients in Laboratory Operations, Assay Development and Information Technology to understand and refine requirements for process improvement and to coordinate activities accordingly.
• Responsible for, with increasing accountability for, creation and review of experimental designs, method validation protocols, plans, procedures, product/process documents and reports to achieve department objectives.
• Responsible for the development and validation of new processes
• Critically review new technology on an ongoing basis to understand suitability towards Q Squared Solutions business strategy.
• Function in a team environment, recognizing that priorities will shift according to business needs and maintain a flexible work schedule.
• Drive the development of new experimental techniques, while maintaining/refining existing techniques, as well as the setup and execution of validation protocols including IQ/OQ/PQ documentation.
• Communicate effectively across functions and manage relationships with internal and external partners and customers.
• Identify new industry/technology trends shaping the area of expertise.
• Support training and guidance of lower level and new staff as required.
• Review and write SOPs and other documents as needed.
• Perform other duties, as assigned.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

• BS/MS in Molecular Genetics or related field, or an equivalent combination of education, training and experience.
• Minimum of 5 years of experience in molecular biology, with significant experience in a laboratory setting developing automation solutions.
• Experience in a clinical laboratory operating under GxP and/or CLIA guidelines and direct experience with clinical trials is preferred.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• Working knowledge of GxP, CLIA and HIPAA requirements.
• Knowledge and experience working with contemporary molecular biology techniques, including DNA/RNA manipulation, qPCR and sequencing.
• Validation of molecular assays methods requiring isolation of nucleic acid and detection using amplification, nucleic acid sequencing, genotyping, or gene expression analysis.
• Excellent planning and organizational skills, as well as maintaining close attention to detail is essential.
• Capable of contributing to multiple projects simultaneously.
• Superior oral and written communications skills.
• Proficient user of standard office productivity software such as Microsoft Word, Excel and PowerPoint, along with basic statistical analysis.
• Experience with Automated Liquid handlers is strongly preferred.

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status