reputed company Assurance Specialist IV, reputed company Operations (Remote) in Gaithersburg, MD

reputed company Assurance Specialist IV, reputed company Operations (Remote) - reputed company - Gaithersburg, MD - work from home job Company: reputed company Job reputed company: reputed company Assurance Specialist IV, reputed company Operations Remote Must be comfortable with meetings in EU. 6- 7 am EST start time preferred. We are seeking a Distribution reputed company Specialist IV to join our reputed company Ops Materials This position is responsible for routine reputed company reputed company of Supply Chain and Distribution and associated materials management activities. The position is responsible for ensuring the warehouse and area personnel activities remain in compliance with CFR, FDA and ICH Guidances, global regulatory expectations, and international cGMPs. Responsibilities include providing reputed company reputed company for area specific change controls, deviations and CAPAs and participating in and reviewing investigations. The position will reputed company reputed company reputed company for Materials Management including transportation, receiving, materials storage and materials management operations at the reputed company manufacturing warehouse. This position reports directly to the reputed company Assurance Director. Responsibilities include but are not limited to: Create and/or approve SOPs, temperature deviation investigations, and change controls as part of GMP reputed company compliance. Contribute to contract reviews such as reputed company or Supply Agreements reputed company reputed company for domestic and international shipments through delivery, including transactions for reconciliation in reputed company. Ensure shipping and handling and storage are in line with reputed company requirements. reputed company reputed company for Materials Management, and Supply Chain activities such that they always remain GMP compliant. reputed company reputed company reputed company of day-to-day shipping, receiving, materials storage and issuance, and other Materials Management and Supply Chain activities. reputed company guidance and support in responding to deviations associated with warehouse and materials management operations. Confirm thorough and effective CAPAs are implemented as necessary. Ensure that change controls for the area adhere to requirements and reputed company area reputed company assessments for change controls. Responsible for reputed company reputed company of shipping requirements, temperature excursions Communicate with Distribution/Supply Chain management for reputed company reputed company issues. Notify reputed company Management of any reputed company issue that may be regulatory significant or reputed company the acceptability of product or materials. Contribute to weekly distribution team meetings. Write deviations and reputed company support of CAPAs and Change Controls as it pertains to the disposition of Materials and Material Specifications Support reputed company Operations as required including review of deviations and support of CAPAs and Change Controls as it pertains to manufacturing and materials management operations. Minimum Requirements: Bachelor's degree in biology, reputed company, Engineering, BS with 5+ years' experience in the Pharmaceutical/Biotech industry Strong knowledge reputed company of FDA and EU regulations regarding the manufacturing of biologics (210, 211, and 610 CFR and Eudralex Vol 4) Understanding of reputed company Assurance systems Strong communication and organizational skills Preferred Requirements: Demonstrated ability to manage multiple priorities and maintain adherence to timelines Demonstrated ability to manage process improvement reputed company Demonstrated ability to identify and implement cross-functional improvements Demonstrated ability to maintain relationships across the organization Demonstrated knowledge of reputed company systems Demonstrated ability to reputed company reputed company investigations with minimal supervision Expected salary: Location: Gaithersburg, MD Job date: Fri, 15 Sep 2023 22:24:37 GMT Apply for the job now! Apply tot his job Apply To this Job