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:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

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: