QC System Specialist
Listed on 2026-06-25
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Regulatory Compliance Specialist, Production QC/QA, QA Specialist - Analyst/Manager
Role Description
Position Summary:
Owns day-to-day execution and coordination of the stability program to ensure compliant study setup, sample management, testing coordination, data review support, and on-time reporting. Partners cross‑functionally to maintain high data integrity, inspection readiness, and continuous improvement. Acts as site laboratory management system (SAP/zLIMS) subject matter expert. Maintains compliance through creation and maintenance of biological product specifications and COA templates. The successful candidate must be a self‑starter and have the ability to prioritize work based on the needs of Production, Quality Assurance, Quality Control, Regulatory, Global Manufacturing Technologies and Supply Chain.
Responsibilities
Stability:
Coordinate stability studies (routine stability, confirmation of expiry, USDA/regulatory commitments, as well as new product registration) in alignment with approved protocols, regulatory requirements and internal procedures. Create and maintain stability schedules, pull plans, time points, and tracking logs to ensure on‑time sample pulls, testing, and reporting. Ensure accurate stability sample receipt, labeling, storage placement, chain‑of‑custody, and inventory reconciliation. Partner with QC, QA, Manufacturing, Regulatory, Supply Chain, Global Manufacturing Technologies and other sites to align timelines, resolve issues, and maintain clear communication.
Prepare and route stability documentation (protocols, amendments, pull schedules, test requests, shipping paperwork, OOS/deviation inputs) with a high level of detail and right‑first‑time execution. Support data review and trending activities; verify completeness and traceability of data packages. Support stability reporting (interim/annual/expiry), including compilation of supporting documentation and readiness for QA review. Identify and elevate risks (missed time points, sample issues, lab capacity constraints) early with proposed mitigation plans.
Support deviation/nonconformance initiation and investigation inputs related to stability activities, tracking actions to closure. Maintain inspection readiness: organized records, clear audit trails, and rapid retrieval of stability documentation. Drive continuous improvement by simplifying workflows, reducing errors, improving on‑time performance, and updating SOPs/work instructions as needed.
Master Data:
Coordinate SAP and zLIMS transactions supporting QC operations (sample log‑in support, status updates, results routing, COA/data package support as applicable). Maintain and control QC‑related master data with a high level of detail (materials, specifications, sampling plans, test methods, stability links, locations, units, reason codes). Ensure data accuracy, completeness, and alignment between SAP and zLIMS; perform reconciliation checks and resolve discrepancies.
Act as primary point of contact for day‑to‑day system issues: troubleshoot, triage, document, and coordinate resolution with IT/Zoetis system support. Develop and maintain job aids, work instructions, and SOPs related to SAP/zLIMS workflows; keep documentation inspection ready. Coordinate periodic reviews (master data, pending transactions/backlogs) and drive actions to closure. Partner with QC, QA, Manufacturing, Supply Chain, MSAT, and external partners to align end‑to‑end processes and timelines.
Support change control deliverables as required. Track workload, KPIs (turnaround time, backlog, right‑first time) and implement continuous improvement to reduce rework and improve on‑time performance. Perform additional tasks as needed to support business priorities and operational resilience. Follow all quality standards, policies and procedures.
BA/BS degree in a scientific discipline or business with 0-2 years’ experience (experience in SAP/zLIMS highly desired) or 8 years relevant experience. Demonstrated commitment to core beliefs and leadership competencies. Works well with others; collaborative team player with professional communication skills. Demonstrated ability to interact positively with all levels of colleagues, including senior…
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