Detail-oriented quality specialist with expertise in regulatory requirements, quality analysis and data evaluation. Highly motivated and analytical with strong collaboration, organization, and communication skills.

HIGHLIGHTS:

Database control

MS Office proficient

Supply forecast

Team player

Audit experience

Project management trained

GMP change management systems trained

Detailed writing skills

Excellent time management

Lean 6-Sigma trained

Laboratory Start-up experience

PROFESSIONAL EXPERIENCE

Merck May 2012 - Present

Associate Quality Specialist Durham, North Carolina

Perform quality control testing on in-stage, on-demand and final live viral vaccine products. Manage mammalian cell lines including MRC-5, RK-13, and Vero.

Operate under cGMP(Good Manufacturing Practices) regulations ensuring accountability through documentation

Certified trainer with successful training experience

Daily documentation of procedures, results and review

Laboratory start-up experience; including maintaining training records, equipment, agents and machinery that may be subject to monitoring by federal and state regulatory agencies

Audit training to sustain a “audit ready” position on a day-to-day basis

Extensively skilled in good documentation practices (GDP)

SOP authorship collaboration with subject matter experts

LIMS (Laboratory Information Management System) experience

Knowledge of FDA regulations and compliance

Charlotte A. Sweeney MD PL Nov 2011 - Feb 2012

Medical Assistant Raleigh, North Carolina

Assisted OBGYN doctor with medical and clerical tasks.

Performed primary medical assessments, obtained vitals, patient history, and chief complaints, gave future visit instructions

Prepared laboratory specimens and performed laboratory tests

Verified records for accurate documentation

Explained medical procedures and results to patients

Assisted the physician during examinations

Prepared patients for examinations

PRA International, 10 week internship Jun 2011 - Aug 2011

Clinical Research Associate Raleigh, North Carolina

Utilized current good clinical practices (cGCP/ICH guidelines) to prepare and document project data. Selected for lead position in internal audit preparation where employee trainings and curriculum vitae were reviewed. Managed research supply distribution for ongoing trials.

Trained in handling and filing essential documents; confidential disclosure agreements, FDA 1572 Forms and IRB/IEC documentation

Worked closely with associate researchers to prepare essential documents for clinical trial submission

Packaged and shipped study supplies for sites

Performed quality control verification within electronic trial master file (eTMF)

Conducted document verification in clinical trial management system (CTMS) and notified project management of discrepancies

Performed site communications and management of issues according to audit procedures

Submitted documents to eTMF per SOP

Conducted internal audits of essential documents using eTMF

Performed billable work and other assigned tasks in accordance with PRA’s Standard Operating Procedures (SOP’s)

Argos Therapeutics, Inc. Jun 2008 - Aug 2009

Molecular Biology Production Associate Durham, North Carolina

Extracted and reproduced RNA from patient samples, HIV positive plasma and renal cell carcinoma tumors, that was used to create personalized, RNA-loaded dendritic cell-based therapies.

Ensured GMP laboratory testing facilities, operations and equipment compliance

Authored and reviewed SOPs ensuring procedures were current and appropriate

Performed daily instrument calibration and maintenance to ensure integrity and quality of test samples

Performed daily air quality, personnel, and area environmental monitoring for each assay

Experienced in cleanroom gowning and activity

Performed process validation of on-going processes for improvement

CellzDirect, Inc. Nov 2007 - Jun 2008

Associate Scientist Durham, North Carolina

Lead Associate Scientist in novel PCR testing of donated human liver tissue for hepatitis. Experienced in hepatocyte cell culturing as well as cell biology characterization.

Performed daily instrument calibration and maintenance according to GMP laboratory standards

Authored SOPs pertaining to creating and maintaining quality SOPs

Performed quality control analysis on hepatocyte samples for cellular growth, quality, and activity

Provided daily documentation of laboratory activities with detailed, accurate laboratory data

Structured process validation to ensure required parameters were achieved to meet project specification

Talecris Biotherapeutics, Inc May 2004 - Nov 2007

Molecular Laboratory Technician Raleigh, North Carolina

Tested human plasma donations using state of the art nucleic acid extraction and polymerase chain reaction (PCR) technology to establish donor suitability and acceptability for use in medical products.

Developed LIMS proficiency with daily use

Promoted to lead troubleshooting tester with liquid handling system and COBAS biological testing equipment

Provided instrument calibration and on-site maintenance training on COBAS equipment

Performed process validation of newly implemented methods for procedures and equipment

American Red Cross May 2003 - May 2004

Laboratory Technician Durham, North Carolina

Extracted component elements from donated whole blood following detailed procedures.

Received, shipped and maintained acceptable volumes of rare blood types, fresh frozen plasma, platelets and cryoprecipitate

Generated detailed reports of all products received, produced, shipped and destroyed following strict FDA guidelines

Utilized Laboratory Information Management System (LIMS)

EDUCATION

East Carolina University Greenville, North Carolina

Bachelor of Science, Biology 2002

Clinical Laboratory Science, Minor

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