Site Quality Systems Coordinator (Fort Worth, TX)

Smith+Nephew•Fort Worth, TX

2d•Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Site Quality Systems Coordinator The Site Quality Systems Coordinator is responsible for the administration, maintenance, and continuous improvement of laboratory quality systems, including the Laboratory Information Management System (LIMS) and analytical instrumentation. This role ensures data integrity, regulatory compliance, and efficient laboratory operations across both networked (software-integrated) and standalone instruments in a GMP regulated pharmaceutical environment. The Senior QC Analyst will collaborate closely with chemists, microbiologists, laboratory staff, and IT partners to ensure that systems and instrumentation U.S. Sponsorship or H1B transfer is not available for this role What will you be doing?

Requirements

Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or related field is required.
3–7+ years in a GMP pharmaceutical laboratory environment.
Hands-on experience with LIMS (e.g., LabWare, STARLIMS, Thermo SampleManager) is required.
Experience with analytical instrumentation and associated software (e.g., CDS systems like Empower or OpenLab) is required.
Strong understanding of 21 CFR Part 11, Data Integrity (ALCOA+), CSV (Computer System Validation), Experience with system validation (IQ/OQ/PQ), knowledge of audit trails, user access controls, and electronic records
Familiarity with both networked and standalone instrument data management.
Strong problem-solving and troubleshooting abilities
Excellent communication and cross-functional collaborationSystem
High attention to detail and organizational skills Documentation Quality

Nice To Haves

Experience supporting regulatory inspections is preferred.
Knowledge of SQL or data querying tools is a plus.

Responsibilities

LIMS Administration & Management Serve as system administrator for LIMS, including user access, roles, workflows, and configuration.
Manage sample lifecycle workflows, test specifications, and data reporting within LIMS.
Coordinate LIMS updates, patches, and validation activities (IQ/OQ/PQ).
Troubleshoot system issues and liaise with IT and vendors for resolution.
Ensure compliance with 21 CFR Part 11, ALCOA+ data integrity principles, and internal policies.
Instrumentation Oversight (Integrated & Standalone) Oversee lifecycle management of laboratory instruments (e.g., HPLC, GC, UV, balances).
Ensure proper data capture from both: Integrated systems (instrument software connected to LIMS/CDS) Standalone systems (manual data entry or local software)
Maintain instrument inventory, qualification status, and calibration schedules.
Support instrument validation and software validation activities.
Data Integrity & Compliance Ensure secure, accurate, and attributable data handling across all systems.
Review audit trails, electronic records, and user activity for compliance.
Develop and enforce procedures for hybrid systems (paper + electronic records).
Lead or support data integrity investigations and remediation efforts.
Quality Systems & Documentation Develop, review, and maintain SOPs related to LIMS, instrumentation, and data handling.
Support deviation investigations, CAPAs, and change control related to lab systems.
Participate in internal and external audits (FDA, EMA, MHRA, etc.).
Maintain system validation documentation and traceability matrices.
System Integration & Improvement Coordinate integration between LIMS, Chromatography Data Systems (CDS), and other lab software.
Identify opportunities for automation and process efficiency.
Lead or support digital transformation initiatives within the lab.
Training & Support Train laboratory personnel on LIMS, instrument software, and data integrity practices.
Provide ongoing user support and troubleshooting.
Develop training materials and ensure training compliance.