Manufacturing Maintenance
Resume:
Greenwood, IN 46143
********.******@***.***
MICHELLE R. PRINCE
Experience
Nov 2005 - Current
Schwarz Pharma/UCB/Kremers Urban
Seymour, Indiana 47274
Packaging Supervisor (11/05 – present)
• Supervises the manufacturing and packaging of designated products from filling of product through labeling of final product according to written manufacturing documents.
• Supervises the cleaning and maintenance of equipment required for product filling, labeling and packaging according to SOPs.
• Reviews documentation associated with manufacturing, evaluation and development activities for completeness and conformance to QSRs. Generates and implements Product Change Requests for manufacturing documents and SOPs as needed.
• Ensures that filling and packaging work areas and equipment are maintained according to QSR guidelines.
• Assists with the specifications, selections, vendor contacts, installation, documentation, validation and training of new equipment in order to comply with QSR and ISO guidelines.
• Derives and supervises efforts to maximize the overall department efficiency.
• Regular auditing of SAP manufacturing entries.
Feb 2001 – Nov 2005
INOVA Diagnostics
9900 Old Grove Road
San Diego, California 92123
Biochemist I (2/01 - 7/02)
• Assisted in the activities associated with the manufacturing of Immunofluorescence slide products and the manufacturing activities of other autoimmune diagnostic products in accordance with established procedures.
• Assisted with the maintenance, growth, harvesting and purification of HEp-2, Crithidia and neutrophil cells according to established procedures.
• Prepared IFA product bulks and sterile solutions required for cell manipulations according to manufacturing documents.
• Assisted with the evalutation of raw materials, in-process materials, and finished reagents associated with IFA products.
• Maintained detailed device history records, laboratory notebooks and associated documentation for all manufacturing activities in accordance with current quality systems regulations.
• Prepared, calibrated, operated and cleaned equipment used in the growth of cells and the manufacture of IFA slide products according to Standard Operating Procedures.
• Maintained manufacturing equipment according to Standard Operating Procedures.
Biochemist II (7/02-3/03)
• Oversaw all experiments conducted by Chemist I
• In charge of all cell culturing, including overseeing and helping Chemist I with their cells
• Developed and initiated growth of mammalian cells on microcarrier beads
• Developed protozoan cell bank
• Organization of Chemist I and some organization of lab assistants
Group Leader (3/03-8/04)
• Led the preparation of immunofluorescent slide products from cell harvesting/purification through slide pouching according to written manufacturing instructions. Inspected in-process product tests for correct performance.
• Led the growth and maintenance activities of HEp-2 and Crithidia cell cultures.
• Led the preparation, calibration, operation, cleaning and maintenance of equipment required to manufacture IFA products according to SOPs.
• Led the preparation of product bulks and sterile solutions required for cell manipulations.
• Monitored the timely evaluation of raw materials, in-process materials and finished reagents.
• Maintained detailed and accurate device history records, laboratory notebooks and associated documentation for all manufacturing, evaluation and development activities in accordance with Quality Systems Regulations.
• Arranged for tissue section slides to be fixed, packaged and counted on a daily basis.
• Led efforts to improve IFA products and manufacturing methods.
• Assisted with the preparation of performance reviews for all sixteen individuals in the IFA group.
• Trained individuals on the technical, recordkeeping and QSR aspects of their position.
• Selected, organized and monitored the work assignments of individuals in IFA.
Supervisor (8/04 – 11/05)
• Supervises the packaging of designated products from filling through final kit assembly according to written manufacturing documents.
• Supervises the preparation, calibration, operation, cleaning and maintenance of equipment required for product filling, labeling and packaging according to SOPs.
• Reviews documentation associated with manufacturing, evaluation and development activities for completeness and conformance to QSRs. Generates and implements Product Change Requests for manufacturing documents and SOPs as needed.
• Supervises the maintenance of all material supplies to meet manufacturing schedules.
• Ensures that filling and packaging work areas and equipment are maintained according to QSR guidelines.
• Assists with the specifications, selections, vendor contacts, installation, documentation, validation and training of new equipment in order to comply with QSR and ISO 9000 guidelines.
• Derives and supervises efforts to maximize the overall department efficiency.
References
• Mike Followell, Schwarz Pharma 812-***-****
• Christine Sykes, INOVA Diag. 858-***-****
Education
1996-2000 Northern Arizona University, Flagstaff Arizona
Bachelor of Science
• Major in Biology
• Minor in Chemistry
1992-1996 Junipero Serra High School
San Diego, CA
• Graduated with honors
• Dean's list
• Member of Who's Who Among American Student
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