Quality Control Manager

Experience Summary

Significant diverse expertise in pharmaceutical product development, and

operations including: Regulatory Affairs, documentation, project

management, contract manufacturing operations, quality auditing, human

resources, employee relations, training, and occupational safety.

Work Experience

Bausch & Lomb Pharmaceuticals, Tampa, FL 1991 - 2010

Regulatory Affairs Specialist August 2008-January 2010

. Managed 30+ projects for 20 products launched in 15 international

markets. Successfully launched 75% ahead of schedule.

. Responsible for project planning meetings, cross-functional team

meetings.

. Responsible for all aspects of labeling including content,

artwork and translation

. Responsible for tracking database to ensure adherence to

applicable timelines.

. Create/update work instructions, checklists, department operating

instructions and/or SOPs for international labeling process

Manufacturing Support Services Facilitator November 2005-August 2008

. Administration and coordination of projects within Manufacturing

Support Services.

. Liaison between external customers and multiple internal departments.

. Organized and maintained the volumes of documents required by FDA.

. Responsible for special product shipments packaged per DOT

regulations.

. Assumed responsibilities for GMP, environmental health and safety

procedure awareness, and compliance.

Behavioral Safety Process Facilitator October 2003-November 2005

. Provided behavioral safety process coordination for the entire

facility

. Trained 500 employees including observers, steering committee members,

and managers

. Implemented the Behavioral-Based Safety Process.

. Provided departmental direction for required observations on a monthly

basis.

. Reviewed, analyzed and tracked observers and observations utilizing

specialized database and Dashboard technology.

. Liaised between facility, executive management and steering committee.

Quality Auditor Inspector February 2002-October 2003

. Conducted final review of in-process manufacturing and packaging batch

records.

. Facilitated investigations and documentation of non-conformance and

complaint issues.

. Facilitated preparation of the Certificate of Analysis and provided

annual product review data.

. Identified and requested applicable information from other departments

required to close out batch records.

. Reviewed and approved equipment sterilization records.

Quality Team Leader March 2000-February 2002

. Responsible for managing designated packaging lines, documentation and

assurance of correct packaging of all areas of designated lines.

. Documented, verified, and approved all Quality Control and Line

Clearance forms.

. Maintained batch folders, and other associated packaging run

paperwork.

. Assigned work to 50+ department associates on both manual and

automated lines.

. Evaluated quality issues with MQA manager.

. Met or exceeded monthly production goals while maintaining compliance

and efficiency.

Education

MBA, March-2010

Strayer University, Tampa, Fl

BS, Business Management, 2004

Florida Metropolitan University, Tampa, Fl

AS Business Administration, 2000

Hillsborough Community College, Tampa, Fl

Other

Numerous training seminars attended and certifications achieved.

References available upon request

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