812-***-****

**** ****** **** **.

Greenwood, IN 46143

icoagl@r.postjobfree.com

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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