Clinical Operations Associate

Bureau Veritas•Indianapolis, IN

1d•Onsite

About The Position

The Lab Services Specialist III ensures that clinical specimens, documentation, and data deliverables are quality-checked according to internal standards, regulatory requirements, and client expectations. This role also ensures laboratory equipment and facilities are well maintained, coordinates repairs and preventative maintenance, and manages lab processes such as equipment calibration. Serving as the main liaison between scientists and vendors, it supports equipment installations and repair ensuring compliance with safety regulations for all critical equipment and spaces. Additional tasks may include making buffers, preparing large batches of reagents/media, or other laboratory needs. This role is expected to have a high level of quality checking, as well as client and vendor interactions with a focus on supporting laboratory research. The ideal candidate will possess a high level of attention to detail, initiative, and will be motivated and forward thinking.

Requirements

Exceptional attention to detail and commitment to data integrity
High proficiency with digital tools (e.g., LIMS, Jira, Signals, dashboards/trackers, etc.) and ability to quickly learn new systems
Must have excellent interpersonal skills – being approachable, demonstrate initiative, adaptable, and project a positive attitude.
Strong foundation in problem solving and process improvement: must be flexible, open-minded, and creative.
Strong project management skills, effective communication skills, self-directed, and must have the ability to multi-task and deliver results in a dynamic environment.
GMARS, Metasys and NIST basic knowledge
Proven consistent pipetting skills and aseptic technique.
Effectively balance competing tasks and priorities.
Ability to learn quickly and work in a team environment.
Understanding of laboratory equipment needs
Strong analytical and problem-solving skills
Knowledge of scientific equipment and materials
Proficient with Microsoft Office (Word, Excel).
Excellent organization and time management skills
Ability to effectively multi-task and rapidly adjust to change.
Maintain high performance and flexibility in a dynamic laboratory setting.
Champions company values
Strong technical aptitude and/or broad technical knowledge in various areas
Technical problem solving and process improvement skills
Motivation to learn higher level activities
Bachelor's Degree in Science, or closely related field
Minimum of one (1) year of lab experience (either through an industry or academic research position)
Minimum of one (1) year of lab instrumentation and maintenance
Previous experience working in a GLP environment and familiarity with analytical instrumentation.
An equivalent combination of education and experience may be accepted in lieu of above.

Responsibilities

Performs analytical run data QC reviews to ensure accuracy, completeness, and compliance with analytical, regulatory, and client-specific requirements
Performs electronic Lab Notebook (eLN) QC reviews to ensure accuracy, completeness, and compliance with analytical, regulatory, and client-specific requirements
Performs Laboratory Information Managements System (LIMS) QC reviews to ensure accuracy, completeness, and compliance with analytical, regulatory, and client-specific requirements
Ensure that laboratory equipment and facilities are in good working order; identify issues and submit repair requests to appropriate vendors. This may include ad hoc repair requests, preventative maintenance, or other related services.
Create, implement, and help maintain department processes which may include pipette calibration, freezer defrosting, decontamination, and/or other lab related functions.
Facilitate new equipment installation, equipment decommissioning, or other lab related services which may require coordination of multiple vendors.
Ensure all equipment and laboratory spaces are properly labelled as defined by local safety regulations.
Prepare buffers, media, or other lab related reagents. This may include making/resuspending reagents.
Track work order status, equipment deliveries, and maintenance orders
Communicate with vendors and build relationships
Utilize electronic notebook system and maintain proper documentation (POs, quotes, SDS files, contracts)
Offer problem resolution, as applicable, for any client issues/questions identified, while aiming to enhance client satisfaction and improve client relations.
Train employees in equipment preparation and procedures.
Follow the guidelines set forth with clients and in the Company Quality, Health, Safety, Security and Environmental policies and procedures.
Comply with clients and Company management systems in accordance with appropriate regulatory agencies.
Follows the guidelines set forth by clients and the Company Quality Manual and Safety / Chemical Hygiene Plan.
Adhere to the requirements of the Company Quality System.
Other duties as defined by Manager, department needs and workload.