Essential Functions

• Responsible for performing and documenting all analytical procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelines.
• Performs routine and moderately  complex data analysis to determine if an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances.
• Identifies and documents potential performance errors or otherwise unusual results and escalates to senior lab personnel.
• Performs and documents hands on training for other Laboratory staff in areas of proven competency as assigned.
• Leads routine quality investigations. Assigns and completes CAPAs and effectiveness verification.
• Oversees the technology transfer of methods and SOPs from other groups within Q2 Solutions.
• Collaborates cross-functionally to ensure assays will be sustainable and scalable in laboratory operations.
• Demonstrates advance knowledge to provide input on technical inquiries and provide leadership in troubleshooting projects, including root cause analysis and advanced problem solving.
• Produces analytical documentation for laboratory assays and associated pipelines across all service areas in the business (i.e. Laboratory Ops, Quality Systems, Information Technology, and Finance).
• Identify and lead continuous process improvement initiatives for laboratory operations, including but not limited to the following responsibilities:
• Review of laboratory metrics to identify initiatives as well as establish additional metrics such as cost savings that are associated with process improvement initiatives.
• Work with stakeholders on process improvement initiatives to present projects and ensure that goals are met.
• Independently identifies and evaluates vendor platforms to enhance delivery.
• Responsible for documentation of all project aspects including formal validations of laboratory methods.
• May present findings to a wide variety of audiences internal and external to Q2 Solutions.
• Shares accountability for lab documentation, ensuring SOP's are accurate by conducting regular reviews, updating as needed.
• Prepares data analysis results for upload to LIMS system under the guidance of senior level staff.
• Prepares buffers and solutions for analysis, as required.
• Performs and documents calibration and maintenance of laboratory equipment as assigned.
• Responsible for producing high quality data and documentation in adherence to timelines in accordance with regulatory requirements.
• Participates in continuing education through self-study, attending in-services and off-site lectures and meetings and prepare programs to share with coworkers.'
• Attends internal design calls and analytical assay review meetings to ensure effectiveness.
• May be responsible for contributing to the design and development execution of routine assays under moderate supervision.
• May act as a back up in any area of daily laboratory operations.
• Supports safety, quality, and 6S requirements and initiatives.
• Complies with company's procedures and applicable regulatory requirements.

Qualifications

• Bachelor's Degree in biomedical-related fields.
• Typically requires >5 years experience in relevant discipline.
• >4 years of experience in a regulated laboratory, with technical expertise in FISH and routine histology.
• Sound knowledge of principles, theories, and concepts in job area.
• Knowledgeable across all assays within the scope of assigned technical area/dept.
• Working knowledge of applicable governing regulatory requirements.
• Strong knowledge of applicable lab techniques.
• Proficiency with laboratory calculations regarding batches and specimens including but not limited to averages, means, standard deviations, and various quality control metrics.
• 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.

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