Operations Analyst

Overview In this FDA-regulated OTC sunscreen manufacturing environment, the Operations Analyst applies GMP knowledge to production data, material traceability, inventory status, documentation and operational improvement. The role reports to the Director of Operations and works cross-functionally with Quality while respecting Quality approval and release authority. Responsibilities Analyze GMP batch yields, material usage, scrap, rework, downtime and manufacturing variances to identify improvement opportunities. Monitor lot traceability and inventory status for raw materials, packaging components, work-in-process and finished goods Coordinate with Production and Quality to ensure scheduling and inventory reports reflect approved material and batch release status. Identify and escalate production discrepancies, documentation. inconsistencies and potential GMP compliance risks. Support batch record reconciliation, deviation trends, CAPA effectiveness data and approved change-control initiatives without assuming Quality approval authority. Maintain GMP data integrity and documentation practices; complete required GMP and SOP training. Identify trends, variances, and root causes: prepare written summaries and visualizations for management. Monitor inventory levels, turns and accuracy and support cycle count and reconciliation reports. Partner with finance to analyze costs, variances and opportunities for savings. Analyze demand forecasts, production capacity and resource utilization to support planning and scheduling decisions. Collect, validate, and analyze data from production, inventory, supply chain and customer-order systems. Collaborate with operations, engineering, and quality teams to identify bottlenecks and inefficiencies while proposing data-driven improvements. Other duties as assigned. Skills Working knowledge of applicable FDA OTC drug cGMP requirements, including 21 CFR Parts 210 and 211. Understanding of batch records, GMP documentation, material status controls, lot traceability, deviations, CAPA and change control. Ability to identify and escalate potential quality or compliance concerns while supporting operational objectives. Strong knowledge of manufacturing concepts (work orders, bills of materials, cycle times, inventory etc.) Ability to manage multiple tasks prioritizes competing deadlines, work both independently and with cross-functional teams. Education and Experience Bachelor’s degree in operations management, Industrial Engineering, Data Analytics, or Supply Chain Management or equivalent on the job experience in lieu of degree. 3+ years of experience in operations, manufacturing or supply chain. Minimum of two (2) years of experience in a GMP-regulated manufacturing environment. Prior experience in a manufacturing or industrial environment is preferred. Experience with ERP/MRP systems, production reporting, inventory controls and GMP documentation practices. Experience working with Food industry, cosmeceuticals, OTC products, dermatology, aesthetics etc. is a plus! Pay: $60,000.00 - $65,000.00 per year Benefits: 401(k) Dental insurance Flexible spending account Health insurance Health savings account Paid parental leave Paid time off Vision insurance Application Question(s): What salary range are you looking for? Education: Bachelor's (Preferred) Experience: GMP: 3 years (Preferred) Ability to Commute: Norristown, PA 19403 (Preferred) Work Location: In person

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