Senior Associate - Quality Control Enterprise Systems (LIMS / LMES / CDS)
A leading biopharmaceutical organization is seeking a Senior QC Enterprise Systems Associate to provide technical administration, system support, and operational management for key laboratory informatics platforms. Working closely with Site Business Process Owners (BPOs), this role ensures the smooth execution, compliance, and continuous optimization of site QC systems, including Laboratory Information Management Systems (LIMS), Laboratory Execution Systems (LMES), Chemical/Inventory Management Systems (CIMS), and Chromatography Data Systems (CDS).
Key Responsibilities
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System Administration & Support: Provide technical support and business administration for site QC enterprise systems, including template building, development, and routine maintenance.
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eProcedure & Master Data Management: Evaluate, build, and implement new or revised electronic laboratory procedures alongside Lab SMEs; update inventory system references and partner with global master data teams.
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Validation & Compliance: Support Computer System Validation (CSV) activities, review quality documentation (e.g., sampling and environmental monitoring plans), and conduct Data Integrity Assessments in alignment with 21 CFR Part 11, EU Annex 11, PIC/S, and GAMP5 standards.
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User Support & Training: Deliver end-user support and instructor-led training programs for laboratory applications to ensure operational readiness and compliance with company SOPs.
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Continuous Improvement & Audits: Lead optimization initiatives to enhance system performance and user experience; participate in site audit and regulatory inspection preparation.
Qualifications & Experience
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Education: Third-level degree in a scientific, technical, or related discipline.
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Experience: Minimum of 3 years in a biotechnology, pharmaceutical, or GMP environment, with direct practical experience using or supporting QC laboratory informatics platforms (LIMS, LMES, CIMS, CDS).
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Technical Knowledge: Strong understanding of analytical lab operations, cGMP principles, data integrity requirements, and computerized system controls.
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Professional Skills: Proven ability to self-teach technical concepts, manage competing priorities under minimal supervision, and demonstrate strong organizational and communication skills.
