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Position Summary
The Sample & Management LIMS Coordinator will support laboratory sample lifecycle activities and Laboratory Information Management System (LIMS) processes within a regulated pharmaceutical or biotechnology environment. The role will coordinate sample receipt, registration, tracking, distribution, testing status, and disposition while ensuring accurate LIMS data, sample traceability, and compliance with approved procedures and GMP requirements.
Key Responsibilities
• Coordinate sample management activities from sample receipt through testing completion and final disposition.
• Receive, verify, register, and track samples within the Laboratory Information Management System (LIMS).
• Create and maintain sample records, test assignments, specifications, and associated information in LIMS.
• Verify sample identification, labeling, quantities, storage requirements, and documentation prior to processing.
• Coordinate sample distribution and delivery to applicable QC laboratories and testing areas.
• Maintain accurate sample status, location, chain-of-custody, and traceability throughout the sample lifecycle.
• Monitor testing status and pending activities in LIMS to support timely laboratory execution and sample completion.
• Review LIMS records and sample documentation for accuracy, completeness, and compliance with approved procedures.
• Support the management of raw material, in-process, finished product, stability, environmental, utility, and other applicable laboratory samples.
• Coordinate sample storage, retention, retrieval, reconciliation, and disposal activities according to established procedures.
• Support LIMS master data activities, including sample plans, specifications, test methods, and other applicable laboratory information.
• Identify and communicate sample discrepancies, documentation errors, LIMS issues, or unexpected conditions.
• Support investigations, deviations, CAPAs, and change controls associated with sample management or LIMS processes.
• Generate and review LIMS reports, sample status reports, and applicable laboratory metrics.
• Collaborate with QC, Manufacturing, Quality, Validation, IT, and other cross-functional groups to resolve sample or system-related issues.
• Ensure sample management and LIMS activities are performed in accordance with cGMP, data integrity requirements, site procedures, and applicable regulatory standards.
• Support laboratory inspections, audits, and documentation requests related to sample management and LIMS records.
• Provide operational support during off-shifts, weekends, or extended-hour activities based on manufacturing and laboratory needs.
Minimum Recommended Qualifications
• Bachelor's degree in Chemistry, Biology, Microbiology, Biotechnology, Life Sciences, Engineering, or a related scientific field.
• At least 3 years of experience within a pharmaceutical, biotechnology, medical device, or other regulated laboratory environment.
• Experience with laboratory sample management, sample coordination, or QC laboratory operations.
• Hands-on experience using a Laboratory Information Management System (LIMS) for sample registration, tracking, testing, or results management.
• Knowledge of sample lifecycle processes, including receipt, labeling, storage, distribution, reconciliation, retention, and disposition.
• Knowledge of cGMP requirements, Good Documentation Practices (GDP), and data integrity principles.
• Experience reviewing laboratory records and maintaining accurate electronic documentation and sample traceability.
• Ability to coordinate multiple samples, testing priorities, and laboratory activities in a fast-paced regulated environment.
• Strong organizational, communication, and cross-functional coordination skills.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
The Sample & Management LIMS Coordinator will support laboratory sample lifecycle activities and Laboratory Information Management System (LIMS) processes within a regulated pharmaceutical or biotechnology environment. The role will coordinate sample receipt, registration, tracking, distribution, testing status, and disposition while ensuring accurate LIMS data, sample traceability, and compliance with approved procedures and GMP requirements.
Key Responsibilities
• Coordinate sample management activities from sample receipt through testing completion and final disposition.
• Receive, verify, register, and track samples within the Laboratory Information Management System (LIMS).
• Create and maintain sample records, test assignments, specifications, and associated information in LIMS.
• Verify sample identification, labeling, quantities, storage requirements, and documentation prior to processing.
• Coordinate sample distribution and delivery to applicable QC laboratories and testing areas.
• Maintain accurate sample status, location, chain-of-custody, and traceability throughout the sample lifecycle.
• Monitor testing status and pending activities in LIMS to support timely laboratory execution and sample completion.
• Review LIMS records and sample documentation for accuracy, completeness, and compliance with approved procedures.
• Support the management of raw material, in-process, finished product, stability, environmental, utility, and other applicable laboratory samples.
• Coordinate sample storage, retention, retrieval, reconciliation, and disposal activities according to established procedures.
• Support LIMS master data activities, including sample plans, specifications, test methods, and other applicable laboratory information.
• Identify and communicate sample discrepancies, documentation errors, LIMS issues, or unexpected conditions.
• Support investigations, deviations, CAPAs, and change controls associated with sample management or LIMS processes.
• Generate and review LIMS reports, sample status reports, and applicable laboratory metrics.
• Collaborate with QC, Manufacturing, Quality, Validation, IT, and other cross-functional groups to resolve sample or system-related issues.
• Ensure sample management and LIMS activities are performed in accordance with cGMP, data integrity requirements, site procedures, and applicable regulatory standards.
• Support laboratory inspections, audits, and documentation requests related to sample management and LIMS records.
• Provide operational support during off-shifts, weekends, or extended-hour activities based on manufacturing and laboratory needs.
Minimum Recommended Qualifications
• Bachelor's degree in Chemistry, Biology, Microbiology, Biotechnology, Life Sciences, Engineering, or a related scientific field.
• At least 3 years of experience within a pharmaceutical, biotechnology, medical device, or other regulated laboratory environment.
• Experience with laboratory sample management, sample coordination, or QC laboratory operations.
• Hands-on experience using a Laboratory Information Management System (LIMS) for sample registration, tracking, testing, or results management.
• Knowledge of sample lifecycle processes, including receipt, labeling, storage, distribution, reconciliation, retention, and disposition.
• Knowledge of cGMP requirements, Good Documentation Practices (GDP), and data integrity principles.
• Experience reviewing laboratory records and maintaining accurate electronic documentation and sample traceability.
• Ability to coordinate multiple samples, testing priorities, and laboratory activities in a fast-paced regulated environment.
• Strong organizational, communication, and cross-functional coordination skills.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*