QA Pharma Compliance Technician – Metrology
NATURE OF WORK This individual will be a part of a team which will implement, support and maintain pharmaceutical cGMP???s and the Quality Management System at the Madison site as needed to assure the compliance of products manufactured by DuPont with all internal, customer and regulatory requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES The essential functions of this position include, but are not limited to, the following: Work with respective areas to establish required GMP???s for compliance in regards to equipment control and maintenance. Provide guidance and support to departments with respect to procedures, equipment, testing, documentation, and other GMP requirements. Lead the creation and modification of procedures to reflect the cGMP practices in regards to equipment and maintenance. Perform equipment labeling and tracking; maintain equipment database and SAP updates; update SAP for new and decommissioned equipment including updates to PM list. Track calibrations in SAP for completion; review calibration records and update SAP. Initiate Out-Of-Tolerance (OOT) reports as needed; assist Maintenance/Production with completion of OOT reports. Conduct training of GMP procedures for applicable areas in regards to internal and external requirements. Work with records management in regards to equipment, shipping, and maintenance records. Perform review of pertinent logs including but not limited to pH production probes, QC pipettes, etc. Assist in providing pertinent documentation (e.g. maintenance work orders, calibration documents, COAs, etc.) in support of validation protocol execution. Perform department internal audits for compliance to internal and external requirements. Participate in deviation investigations with Maintenance and Production support. Support environment of continuous improvement within the assigned area and develop awareness for product and production quality. Ensure adherence to DuPont Quality and Environmental Policies and Procedures. Comply with all Company policies including maintaining a drug free work place. Qualifications:KNOWLEDGE, SKILLS AND ABILITIES Must have a minimum of 5 years of experience in the areas of Production, Maintenance, Metrology, and/or Shipping OR Associate's or Bachelor???s degree in Science or Engineering with hands on work experience handling lab equipment and assessment/calibration procedures. Should have mechanical aptitude and general understanding of equipment, maintenance, calibration and shipping procedures. Experience in a regulated environment preferred but not required. Must demonstrate the ability to recognize trends and facts and the skill for assisting in problem solving and continuous improvement. Possess effective communication, interpersonal, team building skills at various levels with other departments. Must have the ability to work as an active team member. Possess strong organizational and time management skills and the ability to work independently, when needed. WORKING CONDITIONS This position operates in an office/production/laboratory environment. Must adhere to plant GMPs and wear Personal Protective Equipment as appropriate in accordance with plant policy.Apply for this job.