QC System Specialist

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.

Position 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/maintain stability schedules, pull plans, timepoints, 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 Zoetis sites to align timelines, resolve issues, and maintain clear communication.
• Prepare/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 escalate risks (missed timepoints, sample issues, lab capacity constraints) early with proposed mitigation plans.
• Support deviation/nonconformance initiation and investigation inputs related to stability activities, track 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 (e.g., 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), per change control requirements.
• Ensure data accuracy, completeness, and alignment between SAP and zLIMS (as applicable); 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/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 (e.g., 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 Zoetis Quality Standards, Policies and Procedures

Education and Experience:

• BA/BS degree in scientific discipline or business with 0-2 years' experience (experience in SAP/zLIMS highly desired) or 8 years relevant experience.
• Demonstrated commitment to the Zoetis 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 leadership.
• Demonstrated ability to achieve results.
• Strong communication (oral and written), interpersonal, and team/group interactive and leadership skills.
• Strong commitment to product quality, customer service, and continuous improvement.
• Strong organization, prioritization, and follow-through; consistently meets deadlines.
• Detail-oriented with strong documentation practices and data integrity mindset.
• Comfortable managing multiple tasks simultaneously and shifting priorities with minimal supervision.

Technical Skills Requirements:

• Proficient in Microsoft Word, Excel, PowerPoint, Outlook, ETS, Veeva Vault
• Experience with 9CFR & EU regulatory requirements preferred.
• Experience in GMP/GLP environments; stability program experience preferred.
• Understanding of Outlines of Production/Special Outlines preferred
• Experience supporting SAP (QM/MM preferred) and/or LIMS (zLIMS preferred) in a regulated environment.
• Familiarity with ICH stability principles (e.g., Q1) preferred.

Physical Requirements:

• Must be able to walk, sit, or stand for long periods of time.
• Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
• Must be able to work scheduled 40 hours with the ability to work overtime as needed.
• Frequent lifting and carrying of 5 to 50lbs.
• Regular reaching, bending, stooping, and twisting.
• Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
• Must be able to work weekends and some holidays.
• Must be able to wear a respirator
• Capabilities of performing physical labor.
• We sometimes have to lift 50lb feed bags

Full time

Regular

Colleague

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