Q2 Solutions 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, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization's clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.
The Bioanalytical Study Specialist provides bioanalytical study related support by performing tasks associated with the study lifecycle (start-up, maintenance, and closeout). They will work closely with the Bioanalytical Study Lead and Sr. Bioanalytical Study Specialist (if applicable) to learn the procedures and practices necessary to ensure that all project work stays on schedule and is done according to Q2 Solutions' standards. Additionally, they ensure work is conducted in line with standard operating procedures, policies and good practices.
- Provides internal oversight and conducts the day to day running of a project throughout its life at Q2 Solutions, including method development, method validation, and sample analysis while adhering to timelines, SOPs and performance metric standards.
- Provides direct support to the Bioanalytical Study lead.
- Serves as internal liaison between the production lab scientists and Bioanalytical Study Lead.
- Provides daily direction and feedback to laboratory staff regarding bioanalytical studies.
- Effectively and efficiently coordinates and communicates with relevant internal support groups as needed for the study.
- Interacts with other functional areas and/or vendors to resolve problems, enhance processes and service delivery.
- Anticipates and communicates client need/changes internally; drives discussions with Bioanalytical Study Lead
- Contributes to the development of meeting and training materials (e.g. troubleshooting meeting presentations).
- Submits accurate weekly assessment of resource requirements for scheduling purposes.
- Maintains run trackers for assigned projects.
- Provides timely billing information based on study budgets for study invoicing.
- Orders, monitors, and tracks supply and expiration of project related materials and reagents.
- Provides regular project status reports to the Bioanalytical Study Lead and Scheduling Analyst (if applicable).
- May lead internal or external client calls, discussions and/or tasks for regional studies as required and document associated meeting minutes.
- Supports maintenance of project documentation files and internal databases with project information as directed.
- May ensures the archival of all studies in a timely manner in accordance with Q2 Solutions SOP.
- Works with the Bioanalytical Study Lead to investigate failed runs and runs with analytical issues.
- In support of the Bioanalytical Study Lead, investigates and troubleshoots assay problems while working with the assigned Scientist.
- Drafts method procedure and may create bioanalysis plan documents.
- Designs validation experiments and preparations based on FDA guidance and bioanalysis plans.
- May request samples from Sample Management for analysis.
- Imports and processes run data in Watson LIMS or other software. Accepts or rejects run results based on SOPs, FDA guidance, and bioanalysis plans.
- Writes up analytical results and assembles run binders.
- Reviews data (run binders, data tables, etc) for regulatory compliance and scientific quality.
- Assembles data and report tables for quality review and client submission.
- Calculates statistically derived Immunogenicity cut points (only for Immunogenicity studies executed in Marietta).
- Participates in external and internal audits as needed.
- Complies with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.
- Addresses observations and findings from internal quality groups.
- Manage regional or small global studies.
- Interact with internal clients, and work to objectives/timelines.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Strong interpersonal, written and verbal communication, organizational, and time management skills.
- Demonstrated ability to handle multiple competing priorities; utilize resources effectively.
- Demonstrated ability to think critically and problem solve.
- Computer proficiency in the Microsoft Office suite of tools.
- Demonstrated ability to work in a fast-paced environment.
- Ability to establish and maintain effective working relationships across all levels of the organization.
- Ability to follow verbally communicated or draft instructions and procedures.
- Understanding of routine laboratory procedures.
- Ability to clearly describe experimental objectives and data conclusions.
- Understanding of method development and validation of assays preferred.
- Understanding of GLP and GDP preferred.
- Understanding of ligand binding assays (Immunoassay and Immunogenicity) - for Marietta based Study Specialists.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's Degree in a scientific field
- 1-year related experience; or equivalent combination of education, training and experience in GLP laboratory environment.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- Infrequent travel.
Job ID: R1059662