Dept. Of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center Work Values

Daily Duties at Dept. Of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center:

Manage 10 clinical trial studies with drugs or medical devices for quality - Coordinate and write master production records - Check incoming product to include laboratory testing and release products for production - Approve label designs - Verify product labels, components, and products prior to production in accordance with cGMP – Store/inventory controlled/DEA drugs - Manufacture oral dosage forms (tablets, capsules, over-encapsulation, and over-coating) of drugs and/or matching placebo - Perform preoperational sanitation; verify production accountability of product and labels; release product for distribution - Schedule analytical testing of drugs for shelf life and stability testing - Bottle or blister card and label drugs for studies - Label medical devices for serialization - File accountable documents and records - Enter and/or verify Corrective Action/ Preventive Actions for customer complaints, production problems, and internal audits – Vendor audits - Manage drug recall program - Lead Auditor or Auditor for ISO 9001, 15378 internal audit program.

What they like about Dept. Of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

ISO , cGMP, Quality Control, Quality manager, QMS, Internal Audit, CAPA, HACCP

Skills

ISO, cGMP, HACCP, Document Control, FEMA, RCA, CAPA, Quality Management Systems, Lean, 5/6S, Kaizen, Internal Auditor - ISO, Lead Internal Auditor, Audit Program Coordinator, Food Safety/Sanitation Auditor, Manager - People/Programs/Processes/Facilities, Supervisor - Section/Branch/Company/District/Region, Manufacturing - food/drug, Budgets, laboratory - chemical/micro, Recalls - food/drug

These are some of the questions we asked our climbers about their experiences with Dept. Of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center: