Quality Manufacturing

* ***** ******

Lumberton, NC

704-***-**** (cell)

********@*****.***

CAREER TARGET: Quality Professional

Twelve Years of experience in FDA/Government Regulated industry: 12 years in quality roles,

trained employees several employees in the Quality Department Member of Toastmasters,

member of Roche self-audit team, Roche facilitator, member of Roche process improvement

team for the Pegasys and Mircera product lines, member of the American Society of Quality,

received departmental recognition ensuring product is shipped on schedule, received recognition

from Roche Quality Management for excellent work

Awarded-MBA, with a concentration in Healthcare Management, Hoffman Estates, Illinois 2011

Awarded-BS, Biology, Fayetteville State University, Fayetteville, NC 2006

Professional Experience

Roche Carolina, Florence SC 12/2012 to 2014

Manufacturing Quality Assurance Senior Technician

Ensures the timely closure of investigations, Deviations, Corrective and Preventive Actions, and

Laboratory Out-of-Trends and Out-of-Specifications. Possess a working knowledge of Current

Good Manufacturing Practice. Reviewed batch records in a timely manner. Provide support for

business process performance by identifying potential quality that may affect product quality or

regulatory compliance. Provide support for FDA/ regulatory inspections. Coordinate the

resolution of GMP issues, system issues, and nonconforming materials. Review, approve and

revise site SOP’s and batch records. Provide guidance and coaching in the application of GMP in

the facility. Enhance and initiate process improvement activities. Manage the initiation, tracking

and closure of discrepancies. Actively participates in Root Cause Analysis to resolve product

issues. Provided support and guidance to technicians as a Quality representative for the Pegasys

and Mircera product lines. Member of process streamlining team. Perform safety walkthroughs

of the manufacturing areas. Audits all logbooks in manufacturing for accuracy.

Hospira, Inc. Clayton, NC 2006 to 2010

Manufacturing Quality Associate

Reviewed batch records for release of product in an FDA regulated facility. Initiated events in the

CAPA system. Worked with manufacturing to insure the release of quality product. Assisted in

FDA audits by retrieving needed information and resolving batch record issues. Trained three

employees. Member of the Carolina Star team. Member of the safety team. Performed safety

walkthroughs.

Bestsweet, Inc. Mooresville, NC 2002 to 2004, 2012

Manufacturing Associate

Issued and managed batch records. Dispositioned raw materials and final product. Reviewed

batch records, performed hourly line checks, trained six quality professionals, quality

representative for the Neutraceutical Department and the Ludens cough drop line. Assisted in the

validation of the Ludens cough drop line into the facility. Participated in product reviews,

stability studies, performed hourly checks of the product line. Performed microbial swabbing on

equipment. Performed laboratory testing on final product.

Heritage Environmental Services Charlotte, NC 2000 to 2002

Laboratory Technician

Accurately maintained all records in a Federal, and State regulated laboratory. Effectively tested

and interpreted waste products in relation to product specifications. Compiled test results into a

database. Conducted safety walkthroughs. Performed wet chemistry analysis waste streams.

References Available Upon Request

Contact this candidate