Job Overview
Responsible for serving as a technical specialist for laboratory operations, identifying and driving continuous process improvement initiatives.
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 verifications.
• 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 Bachelors Degree Or equivalent combination of education and experience (Some CAP/CLIA lab locations may require a BSc in in a chemical, physical, biological or clinical laboratory science,
medical laboratory technology or cytotechnology.) Req
• Typically requires >5 years experience in relevant discipline. Req
• >4 years of experience in a regulated laboratory. Req
• 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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
iqvia