Experienced individual in all aspects of Pharmaceutical operations, I will contribute right away to benefit your organization.

1/2004 - 9/2008

Ortho-Clinical Diagnostics

Individual Contributor

• • Reviewed, maintained, tracked/trended, initiated, authored all documents and systems directly related to RhoGAM division within a cGMP facility. • Instituted re-engineering of batch records and instituted matrix to capture common batch record errors. • Instituted CAPA and Nonconformances through the use of Trackwise system. • Trained, tracked and trended Nonconformances, Root Cause Investigations, and Product Dispositions. • Performed protein formulation and purification using column chromatography, precipitation and viral removal methods • Performed Quality tasks such as internal monitoring and auditing of floor activities, Plasma Pool Qualifications and incoming and finished inspection.

1/1999 - 1/2004

Ortho-Clinical Diagnostics

Manager

• • Assured the compliance of GMPs by continually monitoring of production technicians, including quality inspection of packaging lines. • Trained and coordinated new and existing employees in new compliance policies from both government (FDA) and company. • Wrote and revised new and existing procedures/policies that affect the department. • Reviewed batch records tracked errors using data base. • Conducted internal audits on a monthly basis. • Tracked and trended all departmental goals; including: cycle time, first pass acceptance, risks assessments, nonconformance, corrective and preventive actions, and product disposition. Associate Protein Specialist Ortho Clinical Diagnostics Raritan, NJ Assistant Immunologist 1992-1997 • Assured the compliance of GMPs by continually monitoring of production technicians, including quality inspection of packaging lines. • Trained and coordinated new and existing employees in new compliance policies from both government (FDA) and company. • Wrote and revised new and existing procedures/policies that affect the department. • Reviewed batch records tracked errors using data base. • Conducted internal audits on a monthly basis. • Tracked and trended all departmental goals; including: cycle time, first pass acceptance, risks assessments, nonconformance, corrective and preventive actions, and product disposition. Ortho Clinical Diagnostics Raritan, NJ Associate Protein Specialist 1997-1999 • Formulated reagents according to specifications and filled documentation regarding departmental operations. • Operated and maintained centrifuges and other equipment used in the department. • Cleaned in and steam in place manufacturing equipment. Ortho Clinical Diagnostics Raritan, NJ • Assured the compliance of GMPs by continually monitoring of production technicians, including quality inspection of packaging lines. • Trained and coordinated new and existing employees in new compliance policies from both government (FDA) and company. • Wrote and revised new and existing procedures/policies that affect the department. • Reviewed batch records tracked errors using data base. • Conducted internal audits on a monthly basis.

7/1997 - 1/1999

Ortho-Clinical Diagnostics

Individual Contributor

• • Formulated reagents according to specifications and filled documentation regarding departmental operations. • Operated and maintained centrifuges and other equipment used in the department. • Cleaned in and steam in place manufacturing equipment

1988

Bachelor Degree

Temple University

• Fine Arts