Quality Associate III
Resume:
DEBRA BROCKERS
*** *. ***** ******, *******, NC *7520 919-***-**** ****************@*****.***
Detailed oriented and driven Quality professional seeking position of SenioSpecialist.
EDUCATION
Shaw University, Raleigh, NC
Aug. 1992 – May 199
Bachelor of Science in Biology
Courses: Epidemiology and Biostatistics, Organic, Analytical, and Biochemistry, Physiology, Microbiology, Vertebrae Anatomy, Embryology, Genetics, Immunology, Zoology, Ecology, Botany, Biology Seminar, and Microcomputer Software
Johnston Community College, Smithfield, NC
May 2011 –2011
Associate of Arts: ASQ Auditing
Relevant Courses: Writing audit plans, audit team segment, schedule follow up assignment
North Carolina State University, Raleigh, NC
Aug. 2012 – 2012
Associates of Arts: International Organization for Standardization (ISO) for 14001 Auditing
Relevant Courses: Conducted audit with audit team, finding deviations from procedures, writing audit plans, scheduled follow up of corrected errors
Johnston Community College, Smithfield, NC
March 2017- May 2017
Six Sigma: Total Quality Fundamenta
Johnston Community College, Smithfield, NC
May 2017- July 2017
Medical Writing: American Medical Writers
Association
Johnston Community College, Smithfield, NC
August 2017-October 2017
Six Sigma: Total Quality Applications
PROFESSIONAL CERTIFICATION
ISO for 14001 Auditing
Jan. 2012 - 2012
WORK EXPERIENCE
Grifols Therapeutics Clayton, NC
Quality Associate III
Nov. 2008 – present
●Audit batch production records
●Audit laboratory testing records for accuracy
●Follow Standard Operating Procedures
●Prepare batch paperwork for final release of products
●Works in a cGMP environment, where FDA21 CFR Part 11, 210, and 211 laws are followed
●Use of systems, such as SQL, LIMS, SAP, Trackwise, EDMS document control system, CITRIX, Charge Control application and Microsoft Office
●Participated in ISO 14001 monitoring
●Communicate with production and laboratory personnel for discrepancies and followed up on corrections
●Daily communicated with customers internationally and domestic.
●Train colleagues on auditing batch production records and testing paperwork
●Conduct departmental safety meetings
●Knowledge of Europe, Canada, United States and other countries requirements and specifications
●Prepare and create training modules for department.
●Represented department at weekly product release meeting
Grifols Therapeutics, Clayton, NC
Quality Associate II
Aug. 2005- Nov. 2008
●Audit batch production records
●Audit laboratory testing records for accuracy
●Follow Standard Operating Procedures
●Use of specific systems such as SQL, LIMS, SAP, Trackwise, EDMS document control system, CITRIX, Change Control application and Microsoft Office
●Shipped samples to FDA for testing
●Communicated with production and laboratory personnel for discrepancies and followed up on corrections
●Knowledge of Canada, Europe, and United States and other countries requirements and specifications
●Conduct departmental safety meetings
Grifols Therapeutics / Talecris Biotherapeutics, Clayton, NC
Quality Technical Compliance Coordinator
May 2003 – Aug. 2005
●Participated in audits
●Audited laboratory results (PCR) and entered in SQL LIMS for approval
●Communicated with plasma centers, laboratories, and other departments for errors
●Document management for the records stored and retrieved
Bayer Healthcare, Raleigh, NC
Laboratory Support Technician
Aug. 2000 – May 2003
●Selected as Laboratory Support Department Trainer for SQL LIMS
●Trained over 150 employees on SQL LIMS including department
●Worked in validation for testing of SQL LIMS system
●Scanned plasma samples into LIMS for laboratory testing
●Initiated detailed problem reports and communicated corrections needed with plasma center managers
●Participated in Annual Batch Review
●Chosen as a consultant for the Kaizen committee, to help reduce paperwork, in order to streamline processes
Bertie Memorial Hospital, Windsor, NC
Outreach Records Manager
Sept. 1999 – Aug. 2000
●Managed diabetic education department
●Interviewed and educated diabetic patients on the importance of their health
●Facilitated diabetic groups on nutrition, medicine, health, and glucometer use
●Scheduled appointments with specialists for patients
●Attended OSHA in-services
TRAINING
ELISA, CMV, Anti-C and Anti-D Testing January 2002
Six Sigma: Total Quality Fundamentals. August 2017- Oct 2017
Six Sigma: Total Quality Applications March 2017-June 2017
Medical Coding
COMPUTER SYSTEMS
Microsoft Office (Word, Excel, Publisher, PowerPoint, and Access) LIMS, SAP, Trackwise, CITRIX
Change Control system, Document Control Management system
COMMITTEE MEMBERSHIPS
Kaizen Committee 2001- 2003
GOALS
To attain ASQ Auditor certification
REFERENCES
Available Upon Request
Contact this candidate