Talecris Plasma Resources Work Values

Daily Duties at Talecris Plasma Resources:

Managed all aspects of quality management systems to include: quality metrics, supplier management, CAPA management, process improvement, medical device and equipment calibration and validation, auditing, remediation, and adverse events. Managed overall operations for 8 plasma centers with 22 direct reports and 300+ indirect reports. Managed overall operations in the collection, processing and testing of raw biologics to be manufactured into injectable medicines for human use. Worked closely with Corporate and Regional Quality Groups along with Consultants to assure that all aspects of Quality Operations were followed that included aseptic processes and product integrity for the release of raw drug material. Represented the company to the FDA and other agencies to include direct involvement on responses and CAPA follow-up. Lead multi-functional departments during the remediation efforts of non-compliant sites with moderate to severe nonconformance such as the destruction of raw material that were reported on BPDRs. Performed cGMP audits quarterly at each site with cross-functional teams to develop, document and implement process improvements and CAPA, if needed. All findings and any necessary changes were reported to Corporate QA/RA for approval.

What they like about Talecris Plasma Resources:

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

Quality, Management, Customer Service, Auditor, Process Improvement, TQM, cGMP, GxP, SOP, Medical Device, Validation, Calibration

Skills

Quality Assurance, Process Improvemnt, Validation, Calibration, Mentor, cGMP, SOP, Multi-Location Management, FDA, Training

These are some of the questions we asked our climbers about their experiences with Talecris Plasma Resources: