A large and reputable CRO in RTP is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, this CRO uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.
location: Morrisville, North Carolina
job type: Permanent
salary: $80,000 - 90,000 per year
work hours: 9 to 5
- Perform and document all specimen test procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelines.
- Complete and prepare documentation in compliance with regulatory and corporate guidelines.
- Exercise good judgment in assessing whether test procedure is proceeding according to expectations and that results are within acceptable tolerances. Perform and document hands on training for other Laboratory Associates in areas of proven competency as assigned.
- Identify abnormal progress of test procedure, potential QC failures, or otherwise unusual results and escalate to Team Lead or Laboratory Management immediately.
- Act as a back up in any area of daily laboratory operations, as needed, and meet expectations of the laboratory associate job responsibilities in that area.
- Oversee the technology transfer of methods and SOPs from other groups within the organization such as Research and 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.
- Demonstrate 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.
- Produce 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).
- 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 identify and evaluate vendor platforms to that may help meet goals of the initiatives.
- Documentation of all project aspects including formal validations of laboratory methods.
- Present findings to a wide variety of audiences internal and external to the organization
- Demonstrated subject matter expertise.
- Demonstrated attention to detail, flexibility, and initiative.
- Demonstrated teamwork/interpersonal skills, project management skills.
- Oral/written communication skills and customer-client orientation.
- Decision making ability, results orientation, problem-solving ability
- Ability to maintain accurate records.
- Ability to maintain clean and efficient laboratory operations.
- Ability to perform fully GLP compliant sample and reference compound custody.
- Ability to provide effective client communication.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Ability to trouble-shoot and perform minor repairs to daily use equipment.
- Basic chemistry knowledge and how it relates to a safety in the workplace
skills: GLP (Good Laboratory Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.