Quality Assurance Training
Resume:
Karen Desjardins
New Bedford, Ma. 02745
E-mail address: *********@*****.***
OBJECTIVE:
To support the Quality Organization further the goals of creating a culture of Quality.
EDUCATION:
Bachelor of Science in Biology, with a concentration in Medical Technology and a minor
in Chemistry and Psychology. Salem State College, May 2001.
SKILLS:
High Performance Liquid Chromatography, Gas Chromatography, Atomic Absorption, Mass Spectrophotometry, UV-Vis, gel electrophoresis, PCR, Kirby-Bauer Method, Slide preparation methods and ELISA-related assay. Have experience with Microsoft Word and Excel.
EMPLOYMENT HISTORY:
10/07- 11/11 MassBiologics Boston, MA
Manufacturing Compliance Specialist
1. Write and Assist with Incident/Deviation reports
• Investigate routine deviations and assisted with complex manufacturing deviations.
• Identify and report Incident/Deviation’s to QA and submit drafts within the required five business days.
• Collect supporting documentation and work with QA to close the report.
2. Change Controls
• Draft change controls as needed for the department
• Close change controls
3. Departmental Training Coordinator
• Schedule and perform training as required by document revisions and CAPA’s
• Gradually taking over role as training coordinator for the department.
• Maintain training logs in accordance with GMP.
• Verify and approve training for the Vaccines Department
4. Planned Deviations
• Draft Planned Deviations
• Gather data for open planned deviations
• Close opened planned deviations
5. Point person for reviewing and auditing departmental process and Equipment
Logbooks
• Developed and Implemented schedule for auditing process and equipment logbooks
• Developed and implemented a spreadsheet to document findings commonly observed when reviewing logbooks
• Developed and implemented a spreadsheet (Monthly Logbook Audit Report) to be used by auditor to record findings when reviewing logbooks in the lab. If there are any findings, the auditor is to give this report to the responsible manufacturing manager for that area.
• Track and follow up on logbook issues with manufacturing managers.
• Ensure entries in Logbooks are made accurately, organized and are up to date
• Maintain Logbooks in accordance with GMP
6. Facility Cleaning Logs
• Daily and monthly review of cleaning logs ensuring the facility is cleaned per SOP.
• Ensure entries in cleaning logs are made accurately, organized and are up to date
• Maintain cleaning logs in accordance with GMP record keeping SOP
• Ensure additional cleanings were performed and documented
7. Verification of Trending Data
• Verify production data (Diphtheria, Tetanus and Compositing) for trending
8. Batch Production Record review
• Responsible for reviewing Master Production Records
• Ensure completed and reviewed Production Records are submitted to QA within the required five business days
9. Revise Departmental Standard Operating Procedures and Batch Production Records
• Revise batch records, solutions records, SOP’s and in-process forms
10. Particle Counter Data
• Download and review particle counter data following formulation
of the Tetanus and Diphtheria Vaccine (Compositing)
09/03 to 10/07 Amgen W. Greenwich, RI
Plant Quality Assurance Associate
• Review of Manufacturing Procedures, Standard Operating Procedures, Logbooks
(both on and off the Production floor), and Equipment Use Records
• Work Order Pre-Approval and Post-Approval
• Nonconformance Class 1 Closure Program
• Validations Protocol and Report Review and Approval
• Generating/Compiling quality data and reports from quality systems: LIMS, QCDS, QACMS, ERP System, Livelink,Lot track/trace, Nonconformances and CAPAs (Trackwise)
• Review for Quality approval SIP and CIP reports and Autoclaves in support of Enbrel® manufacture
• Participated in internal plant audits and trained in Site Compliance Program
• Trainer for the QA department- Train new individuals that are hired into the department as well as cross-training between facilities
08/01 to 09/03 Amgen W. Greenwich, RI
Manufacturing Associate
Area: Cell Culture: Proficient in the following responsibilities:
• Clean in place
• Steam in place
• Integrity Testing of Filters
• Bioreactor Manipulations
• Process Monitoring
• Follow SOPs to conduct all operations in an aseptic manner
08/95 to 02/96 Walgreens Pharmacy Salem, NH
Pharmacy Technician
• Daily interaction with customers
• Data entry, answering telephones
• Filled prescriptions
• Inventory Control
03/95 to 08/95 Bradlees Department Store Salem, NH
Fashions Department Associate
• Daily interaction with customers
• Answering telephones
• Cashier
• Responsible for inventory and stock of merchandise
•
11/94 to 02/95 CVS Pharmacy Framingham, Ma
Pharmacy Technician
• Daily interaction with customers
• Data entry, answering telephones
• Filled prescriptions
• Inventory Control
Achievements:
• The 2001 Salem State College School of Arts and Sciences Undergraduate Research
Symposium ( presentation: “Detection of Tetracycline in Chicken Tissue By Use of the HPLC
Method”)
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