Responsible for tasks performed at Fluorescence In-situ Hybridization (FISH) lab, including wet lab methodology, analyzing the FISH slides, and preparing the reports. Leads trouble shooting and process improvement.
- Works under limited supervision in accordance with policies and procedures to perform routine activities involved in the preparation of slides for microscopic evaluation by pathologist(s).
- Partners with Pathologist(s) to facilitate analysis and timely delivery of results.
- Operates and performs routine maintenance on histology laboratory equipment.
- Responsible for performing FISH and IHC technical processing.
- Responsible for performing staining procedures to support pathological assessment.
- Exhibits team leadership skills by mentoring, guiding, and providing technical expertise on specialized techniques to team members and training of junior staff.
- Demonstrates advanced domain knowledge to provide input on technical inquiries and provide leadership in troubleshooting projects, including application of root cause analysis and advanced problem-solving techniques.
- Responsible for maintenance and troubleshooting of relevant equipment.
- Ensures compliance with all local, federal, CLIA and CAP regulations.
- Identifies and leads continuous process improvement initiatives for laboratory operations, including but not limited to the following responsibilities:
- Conducts regular review of laboratory metrics to identify initiatives as well as establish additional metrics such as cost savings that are associated with process improvement initiatives.
- Works with stakeholders on process improvement initiatives to present projects and ensure that goals are met.
- Independently identifies and evaluates vendor platforms to that may help meet goals of the initiatives.
- Maintains proficiency and training requirements.
- Assists in process improvements to increase data quality, lower costs, or reduce turnaround times to include, updating SOPs, assisting with troubleshooting.
- Ensures proper documentation in accordance with good documentation practices, SOP's, and regulatory guidelines.
- Oversees lab validations and the technology transfer of methods and SOPs from other groups within Q2 Solutions such as Assay Development departments. This includes working with those departments to fill gaps that are identified to ensure the technology will be sustainable and scalable in laboratory operations.
- Produces technical documentation for laboratory assays and associated pipelines across all service areas in the business (i.e., Laboratory Ops, Quality Systems, Information Technology, and Finance).
- Appropriately documents all project aspects including formal validations of laboratory methods.
- Presents findings to a wide variety of audiences internal and external to Q2 Solutions.
- Serves in a general supervisor role per CAP definition.
- Supports management in ensuring proper lab documentation.
- Assists with SOP writing and review.
- May release lab results based on local regulatory requirements.
- Assists in good housekeeping of the lab environment, consistent with 6S standards.
- Supports safety, quality, and 6S requirements and initiatives.
- Complies with company's procedures and applicable regulatory requirements.
MINIMUM EDUCATION REQUIRED AND EXPERIENCE
- High School Diploma or equivalent required.
- Candidates will be considered with cytogenetics technologist certification OR at least 5 years of experience in situ hybridization.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
- Detailed knowledge and hands-on proficiency with performing histology techniques, specialized laboratory equipment, clinical testing procedures, staining techniques and applicable laboratory testing regulations.
- Ability to troubleshoot laboratory equipment and resolve process issues.
- Good computer skills including proficiency with Microsoft Excel, PowerPoint, and Word.
- Excellent oral and written communication skills.
- Strong organizational skills, and close attention to detail are essential.
- Capable of handling multiple tasks simultaneously and independently.
- Demonstrated “everyday leadership” skills.
- Ability to maintain a minor degree of independence to complete assigned tasks and projects.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Ability to synthesize information from various topics.
- Ability to bring projects and deliverables to completion under timeline expectations.
- Applicable certifications and licenses are highly desired for this role.
Q² Solutions,IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. 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
Q² Solutions’ ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding COVID-19 vaccination status.https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-statusThe potential base pay range for this role, when annualized, is $82,900.00 - $124,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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Senior Director, Global Central Lab Operations
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