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Senior Specialist - QA (Inbound and Outbound Distribution and Receiving)

Scorpion Therapeutics

Senior Specialist – QA (Inbound and Outbound Distribution and Receiving) As Sr. Specialist – QA, you will support product distribution and material receipt in compliance with USDA regulations and internal standards, ensuring product quality, regulatory compliance, and accurate documentation while partnering with Regulatory Affairs, Supply Chain, and Customer Service. Responsibilities Manage QA release activities for raw materials and finished goods, including SAP transactions and USDA Form 2008 submissions Inspect and verify labeling, documentation, and regulatory compliance for domestic and international distribution Coordinate sampling, testing, and retention programs in alignment with USDA and internal quality standards Support investigations, deviations, complaints, and recalls; recommend corrective actions as needed Maintain and develop QA documentation, including SOPs, quality agreements, and material specifications Minimum Qualifications Bachelor’s Degree or equivalent experience Demonstrated experience in quality assurance, regulatory compliance (USDA/FDA), and/or distribution/logistics environments Strong attention to detail and advanced communication skills (written and verbal) Preferred Qualifications Experience working with SAP or quality management systems (e.g., Veeva) Knowledge of USDA/APHIS regulations and 9CFR requirements Experience supporting audits, supplier quality, or quality agreements Ability to manage multiple priorities in a highly regulated environment Experience training teams on quality or compliance processes Additional Information Travel: Minimal (as needed) Location: Winslow, ME Manufacturing Site Benefits Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) 8-week parental leave Annual bonus offering Up to 6% 401K matching #J-18808-Ljbffr

Vacancy posted 2 days ago
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