Carl Rush
Director of Operations @ Sentry BioPharma Services, Inc.
About
Twenty (20) plus years’ experience in the medical device, pharmaceutical, and clinical trial industries; Quality, Supply Chain, Logistics and Operations. Led Supply Chain program for seven (7) years developing and promoting Supply Chain operators, with no adverse business impact. Over eleven (11) years in leadership roles with direct reports, fostering an environment of continuous improvement and employee growth. In 2017, engaged in successful Swedish MPA regulatory inspection for company’s first EU GMP certificate. Experienced in participating in internal audits, client audits and regulatory inspections from FDA, Swedish MPA, DEA, BARDA, and Indiana Board of Pharmacy resulting in zero significant findings. Experienced in managing and reviewing Quality elements such as Change Management, Deviations, Warehouse Record Review, CAPA, Complaint Handling, Material and Supplier Management, and Quality/Technical Agreements of Clients. Experience in use of SAP/ROSS (Inventory Management System), HAZMAT, DOT (Hazardous Materials Transportation) and IATA (Dangerous Goods).
United States
Bloomington
Biotechnology
GMP, FDA, Pharmaceutical Industry, Sop, Medical Devices, Clinical Trials, Project Management, 21 CFR Part 11, Microsoft Office, Supply Chain, Quality Control, CAPA, Quality System, Quality Assurance, Supply Chain Management, Validation, V&V, SOP, U.S. Food and Drug Administration (FDA)
Experience

Senior Logistics Analyst
Indianapolis, Indiana Area
Coordinating and monitoring progress to ensure achievement of timelines and goals. Managing and oversight of day to day logistics operations with two direct reports. Completing thorough, timely and well-documented performance evaluations and interim progress reviews. Establishing and monitoring performance objectives for both direct reports and vendor management, taking corrective action where appropriate. Identifying appropriate successors/deputies for all key roles within the team. Plan and develop resources and skills required for the successful execution of the Logistics strategy. In conjunction with Sales and Project Management, monitors, tracks, manages and ensures resolution of all customer complaints, issues and concerns. Ensures all services failures are identified, tracked and resolved in a timely manner. Takes preventative actions to ensure that the same service failure(s) does not occur again. Instills a culture of continuous improvement, quality, productivity and profitability. Effective and timely adherence to management communications, meetings and procedures. Vendor management and metrics to maintain and grow vendor relationships.

Manager Supply Chain
Bloomington, Indiana Area
Actively manage day to day operations of a Good Manufacturing Practices (GMP) warehouse for clients in the pharmaceutical industry. Responsible for warehouse capacity planning, forecasting, and managing budget to meet client demand and potential new prospective opportunities. Supervising one (1) Supervisor and ten (10) supply chain management employees to complete customer requests for shipping, receiving, and procurement (materials management). Assist clients with understanding best solutions for their needs to support their clinical trials (cold chain management, lane validation and qualifications, logistic opportunities). Engaged and participate in client audits and regulatory inspections (FDA, BARDA, DEA, Indiana Board of Pharmacy) by leading warehouse tours and providing answers and objective evidence related to the Supply Chain Management department. Serve as lead DEA representative for controlled substance activities for organization; reporting schedule II through V drugs quarterly. Responsible for ensuring accuracy and completion of SOP revisions (Change Control), Deviations, Corrective Actions (CAPAs), and Process Improvement for the Supply Chain Department. Conducts staff performance reviews, disciplinary actions, hiring personnel, and training as needed to comply with company policy and procedures.

Supply Chain Management Supervisor
Bloomington, Indiana Area
Supervised day to day operations of a Good Manufacturing Practices (GMP) warehouse for clients in the pharmaceutical industry. Supervised eight (8) supply chain management employees to complete customer requests for shipping, receiving, and procurement (materials management). Assisted clients with understanding best solutions for their needs to support their clinical trials (cold chain management, lane validation and qualifications, logistic opportunities). Engaged and participate in client audits and regulatory inspections (FDA, BARDA, DEA, Indiana Board of Pharmacy) by leading warehouse tours and providing answers and objective evidence related to the Supply Chain Management department. Drafted SOP revisions (Change Control), Deviations, Corrective Actions (CAPAs), and Process Improvement for the Supply Chain Department. Conducted staff performance reviews, disciplinary actions, hiring personnel, and training as needed to comply with company policy and procedures.

QA/RA Associate
Bloomington, Indiana Area
Inspected and approved incoming material from clients according to product specification to make sure quality of product has not been compromised. Notified site management and investigate any issues that might arise from incoming materials while following the appropriate deviation and/or CAPA procedures to resolve issues. Inspected and approved outgoing client shipments to ensure orders were accurate and complete to client request. Reviewed and updated documentation through the change control process.

Quality Assurance Document Control
Bloomington, Indiana Area
Responsible for creating new documents as new requests/proposals were generated and approved by: production, engineering, quality assurance, marketing, and regulatory affairs departments. Updated, revised and maintained document library which included product and facility specifications, quality control specifications, manufacturing instructions, quality systems policies, and quality systems procedures. Communicated both verbally and written with all levels of company to facilitate design and implement new company confidential documents and processes. Worked to move hard copy documents into electronic versions (Word or PDF) as part of quality initiative regarding Livelink (Document Management System) compatibility.
Carl Rush's Contact Information
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