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Lead Laboratory Specialist

2 months ago

Round Rock, Texas, United States Round Rock ISD Full time
About the Role

We are seeking a highly skilled and experienced Senior Research Scientist to join our team at Round Rock ISD. As a key member of our Scientific Affairs department, you will play a critical role in supporting testing, method development, and validation.

Key Responsibilities
  • Method Development & Validation
    • Develop validation plans, validation summary reports, stability summary reports, correlation plans, and correlation summary reports to meet regulatory requirements.
    • Provide supporting information to Scientific Affairs in the evaluation of appropriate testing and/or methodology.
    • Liaise with technical staff on feasibility of testing for new study requirements.
    • Provide pricing as needed to Proposals team.
    • Selection of appropriate test methods; research/identify suppliers of laboratory consumables and equipment options for new tests to support clinical trials opportunities.
    • Facilitate assay development, conduct instrument validations, and implement new testing to meet the needs of clinical trials protocols, clients, and regulatory requirements.
    • Support and develop laboratory scientists and train in new techniques and analytical systems.
    • Perform test setup activities in support of the validation of new and/or existing tests and analytical systems.
    • Proactively keep up with industry trends and assist in building new capabilities and service lines.
    • Responsible for assay/panel pre-validation and validation and correlation testing globally.
    • Develop and validate complex analytical methods in a regulatory environment to support clinical trials acting as the Subject Matter Expert.
  • Process Improvement & Quality Support
    • Working with Scientific Affairs, facilitate the standardization of testing SOPs and instrumentation and the harmonization of test reference ranges to facilitate the consistent execution of global studies.
    • Lead the investigation and corrective action for assay troubleshooting and proficiency testing failures.
    • Assess the impact of manufacturer communications and complete associated documentation.
    • This position is the point person for vendor escalations.
    • Document and ownership of any quality documentation (Note to File, Quality Event, CAPA, deviation, change control) as appropriate within the required timeframes.
    • Lead all activities that seek to ensure compliance with GCP guidelines and accreditation schemes (e.g. CAP).
    • Comply with policies for the safe, secure, and confidential processing and storage of patient/client data and other laboratory information.
    • Actively participate in method review and/or improvement.
    • Ensure all methods and validations are done according to all applicable regulatory guidelines, including but not limited to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP).
    • Prepare Analytical or departmental Standard Operating Procedures (SOPs) for newly developed test procedures and relevant documentation as necessary.
    • Promote and support a culture of audit readiness within ACM Global Laboratories.
    • Preparation and review of documentation for participation in internal/external audits.
  • Effective Communication
    • Provide supportive information for consultation and technical support to clinical trials clients and operational staff.
    • Lead communications (meetings, calls audits etc.) with clients and formulate responses as required.
    • Work with other functional areas to drive and implement improvements to quality standards and performance within ACM.
    • Perform other duties as assigned.