Supply Chain Specialist / Senior Specialist

ABOUT THE ROLE

The Supply Chain Specialist manages day to day cGMP supply chain operations, including material receipt, quarantine/release segregation, staging, issuance, and cold chain/ambient shipping. Because we operate in a highly regulated pharmaceutical CDMO environment, this position requires strict adherence to Good Documentation Practices (GDP) and pristine record keeping. Success in this role requires a compliance first mindset, extreme precision, high personal ownership, and customer service orientation to both internal and external customers.

KEY RESPONSIBILITIES

·         Good Documentation Practices (GDP) & Audit Readiness: Execute precise, contemporaneous documentation for receiving, material transfers, issuance, and outbound shipping with zero tolerance for record keeping shortcuts. Maintain audit ready paper and electronic logs.

·         Receiving, Segregation & Inventory Control: Perform GMP receiving, quarantine/release/rejected material segregation, cycle counts, and expiry tracking. Actively support clean dataset preparation and master data hygiene to enable future ERP deployment.

·         Picking, Staging & Batch Support: Accurately pick, stage, issue, and return materials and consumables for GMP and non GMP manufacturing runs according to strict SOPs.

·         Cold Chain & Outbound Shipping: Prepare, package, and document temperature sensitive domestic/international shipments (15 to 25°ree;, 2°ree;C to 8°ree;C, -20°ree;C, -80°ree;C, -196°ree;C), maintaining strict chain of custody and temperature logs and labeled appropriately according to IATA and CFR 49 regulations.

·         Non-Conformance & Facility Care: Promptly report material discrepancies or documentation errors in partnership with Leadership and Quality Assurance. Maintain clean, compliant, and safe supply chain work zones.

QUALIFICATIONS & REQUIREMENTS

·         Education: High school diploma required; Associate or Bachelor's degree preferred.

·         Experience & Title Level: Minimum 3 to 7+ years of experience required, with title (Specialist or Senior Specialist) determined by experience level and demonstrated proficiency. Prior experience in a regulated environment (cGMP, Pharma, Medical Device, or Dietary Supplements) is required.

·         Compliance & GDP Mindset: Demonstrated understanding of cGMP and Good Documentation Practices (GDP). Must view physical/electronic record keeping as equal in importance to physical material movement. Must have legible handwriting.

·         Data & Systems Discipline: High detail orientation with logs, lot numbers, and spreadsheets. Readiness for future ERP integration (e.g., Infor, SAP, NetSuite).

·         Logistics & Cold Chain: Experience handling temperature controlled materials and preparing regulated cold chain shipments. Certification in Dangerous Goods Shipping per IATA and 49 CFR Parts 100-185 a plus.

·         Physical Requirements: Ability to lift up to 50 lbs, operate material handling equipment safely, and work in ambient and cold storage environments.

CORE COMPETENCIES