Quality Assurance Pharmacy Technician
Resume:
Harry Jackson Jr
Clementon, NJ 08021
***********@*******.***
Quality Assurance professional with over 20yrs of experience in the Pharmaceutical/ Biotechnological industry. Extensive experience in ensuring all regulatory compliance activities, DEA, cGMP/cGDP, ISO 9002/QS-9000, and the companies SOPs and policy requirements are met by manufacturing personnel. Proficient in performing internal audits, BR reviews for completeness and documentation errors, review of protocols, SOPs and In-process risk assessment for nonconforming products. Familiar with Trackwise, Compliance Wire, and SAP software. Trained and Certified New Jersey State Pharmacy Technician and Medco trained Six Sigma Green Belt Certification.
PROFESSIONAL EXPERIENCE:
Charles River Labs, Malvern, Pa
10/24/2016-current
Quality Assurance Auditor 11
Independently perform audits of a broad range of records, reports and inspections of a variety of processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures. In the GMP facilities, also responsible for approval and release of the finished product for distribution to clients
Assure Charles River’s compliance with applicable federal, state and local regulations to avoid any business interruptions. Communicate all identified compliance and quality risk to supervisor.
Perform data audits to assess that records are attributable, legible contemporaneous, original, accurate, and in compliance with regulations, SOPs, protocols/batch records and corporate policies and procedures.
Identify, document an report deviations form regulations, protocols/batch records,
SOP’s and specifications
Assist in scheduling and tracking QA audits, inspections and procedures as requested
Aerotek/AstraZeneca, Philadelphia, PA
03/18/2013 – 07/2016
Quality Assurance Inspector (contractor)
In-process testing to ensure product met the BR specifications
Reviewed batch records for completeness and accuracy
Performed internal audits of manufacturing areas and logbooks
Performed pre and post line clearances, equipment challenges, component approval, and label verification
Observed packaging operations to ensure BR protocol, SOP and regulatory compliance
Makes real time decisions on GMP and quality compliance issues
In-process risk assessment for nonconforming products
Reviewed cold chain documents
Used Trackwise to ensure investigations, CAPAs, planned and unplanned deviations are addressed in a
Medco Health Solutions, Willingboro, NJ
10/01/2001 – 11/30/2012
Quality Specialist, 3rd shift
Registered Pharmacy Technician for State of New Jersey
Coordinate Pharmacy Technicians at QA 1 stations
Identified non-conformances, documented and reported deviations, ensured all investigations and deviations are addressed in a timely manner.
Audited In-process and labeling/packaging operations for compliance to cGMPs and company policies/procedures
Review BR documentation for compliance
Performed label verification, final product inspection, product shipment approvals
Participated in projects and tasks to support QA Manager
Revised and review SOPs applicable to Quality
Approved change control
Report weekly to Supervisor/Operations on audit activity
Wheaton Glass, Millville, NJ
2/05/01 – 6/11/01
Quality Assurance Representative
Liaison between Customer Service and Quality Dept.
Development of A.Q.L. programs/Establish limit samples
Maintaining Quality Job Cards/Process capability reviews/SPC
Plant Audits/Certification programs/ Travel to customer facilities
Investigate and resolve customer complaints
Used SAP 4.6 and SAP/3 inventory management systems
PRECISE IML, Swedesboro, NJ
1/25/00 – 10/6/00
Quality Assurance Technician
Insured compliance of product to customer requirements by performing visual and mechanical inspection with processes, specifications and work procedures
Used Lot Release system and other computer systems to enter, verify and gather data, generate print outs and COA
Supervised temporary workforce (5-20 persons) regarding final inspection and packing issues
Traveled to customer facilities to represent Company regarding customer concerns and issues
Coordinated operations regarding inspection and introduction of product into production operations, including Line Clearances
Trained and experienced using in the use of Computer Measuring Machine (CMM) and DATA Page
Certificate of training: ISO 9000 Internal Auditor Class
Danville Regional Medical Center, Danville, VA
10/25/98 – 1/00
Lead Receiving Clerk
Supervise 3-8 Associates
Accountable for coordinating the receiving Clerks scheduling and activities to ensure responsible, accurate receipt, documentation, and delivery of all hospital supplies and capital purchases (Worth twenty million dollars)
Generate documentation that initiates payments to vendors for purchases
Packed and shipped medical devices and pharmaceuticals, including temperature sensitive drugs
Certificates of Completion: Word 97, Word Intermediate, Excel 97 Worksheets, Excel Charting and Graphing & Organizing Data
Used Matkon material management system, Operate electric and manual forklift
EDUCATION AND PROFESSIONAL DEVELOPMENT:
Rutgers University, Camden, NJ 9/94-5/97; 9/00-5/01 Human Service/Sociology. 102 credits, Senior
University of North Carolina at Greensboro, 1999-Junior/Sociology
Camden County College, Camden, NJ 9/91-6/94; Human Service; G.P.A 3.18
Certificate of Completion Statistical Methods and Process Control
Certificate of Training: ISO 9000 Internal Auditor Class
Kane Business School: Computer Business Training- Completion 1988
HONORS:
President's List (1992), Dean's List (1993), Camden County College; Fall Semester 1992
Member in American Society for Quality (ASQ)
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