Clinical Operations Associate

Overview:

Business Title: Clinical Operations Associate

Position Title: Laboratory Support Technician III

Division: Consumer Products Services

Entity: ATL

Location: Indianapolis, IN

Reports to: Manager

FLSA: Non-exempt

Hours Worked: Typically, Monday through Friday, forty-hours per week.

However, must be flexible to meet the needs of the department and complete other projects as assigned.

Position Summary:

The Lab Services Specialist IV 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.

Duties and Responsibilities:

It is everyone’s responsibility to live out our Values and Absolutes by Shaping a World of Trust while ensuring responsible progress.

• 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.

Skills & Proficiencies:

• 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

Education and Experience:

• Degree requirement: 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.

Compensation Range: $26.00-$28.00 per hour  (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as location, education, experience, and skillset).