- 05/1996 - 08/2003•Seven plus years of pharmaceutical experience working with GMP-compliant systems, plus other controlled documents and related quality systems, with thorough knowledge of company and regulatory agency standards
•Efficient trainer/supervisor on new or revised business procedures and/or cGMP systems
•Proven track record as a leader and team player, meeting and exceeding new challenges and company goals/requirements
•Self-motivated and ability to function effectively in a high-stress environment under minimal supervision
•Strong interpersonal and organizational skills, interfacing well with other employees and departments at all reporting levels08/2003•Perform compliance review and approval of product Manufacturing Procedures (MPs) and supporting documentation for Cell Culture and Purification API lots (EPOGEN® and ARANESP™) under minimal supervision.
•Field and resolve basic quality related issues, product or process deviations, MP corrections, and make decisions based on sound understanding of appropriate compliance standards and company procedures.
•Advise senior management of any work disruptions or major quality issues related to product or process operations, which warrant resolution.
•Perform in-house audits of manufacturing operations and area walkthroughs
- 1989 - 1995
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