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  1. 1. Donna Jenkins 2565 Mint Julep Drive Creedmoor, NC 27522 919-339-8077 (c) Experience Professional with nine years’ experience in biotech, including: cGMP, GxP compliance, 21 CFR Parts 11, 210 and 211, Project Management, Quality Control, Quality Assurance,biotechnology,clinical trials, technical writing, data review and analysis, batch record review, manufacturing production scheduling. Documentation Specialist 1 Pearl Therapeutics Durham, NC April 2015 – Present Summary Assists and supportsthe organization with compliance and ongoing conformance to established quality assurance systems and processes. Responsible for maintaining Pearl's documents, both hard copy and electronic. Assists with systemadministration of the MasterControl electronic document management system,ensuring control of internal policies, procedures,specifications, and other GXP documentation. Works extensively with ECM and SharePoint to update documents as appropriate. Responsibilities Responsible for maintaining internal controls over quality policies, procedures, and specifications by assisting in performing the Doc Control function in MasterControl. Creation and issuance of controlled documents, including laboratory notebooks and logbooks. Responsible for document scanning and archival. Maintains Quality systems and documentation. May perform protocol, data, and report review to verify conformance to applicable SOP and regulatory requirements. Supports GXP compliance and inspection readiness within organization. Assists with coordination activities during regulatory inspections. Other QA duties as needed. Skill set: GDP, Master Control, ECM, SharePoint, GxP compliance, GLP, GDP, cGMP Home Educator Sapere Aude Classical Academy May 2008 – February 2015 I was a home educatorto my kindergartner and second grader. We use the classical approach to education which includes reading proficiency during the elementary years,reading lots of classic literature and focusing on history to gain a perspective of our past from creation to present day, and Latin to expand the English vocabulary. We were involved in a group called Classical Conversations that enhanced our home studies.At the end of the 2013 school year, my then 2nd grader was tested using the Woodcock Johnson test,a nationally recognized scholastic achievement test.Through our hard work and his perseverance,he scored on or above grade level in each subject and scored on a 6th grade reading level and a 5th grade reading comprehension level. He is in public schoolthis year, through his choice. My focus was to cultivate a love of learning which will facilitate critical thinkers.
  2. 2. Environmental Monitoring Project Coordinator Argos Therapeutics Durham, NC April 2006 – May 2008 Summary Project Coordinator in the QC Department for the implementation of MODA Technologies,a 21 CFR Part 11- compliant paperless environmental monitoring system.In conjunction with the Validation group, the system was up and running within a matter of months, eliminating countless papermaterials that were previously necessary to perform EM in the manufacturing suites. Responsibilities Project Manager for the implementation of MODA Technology Partner’s MODA-EM at Argos,and served as organizational interface between MODA Technologies and Argos Therapeutics. Supplied MODA Technologies with documents necessary for tech transfer and implementation of MODA-EM into the existing EM program at Argos Therapeutics and authored SOPs and Item Specs related to/required by MODA - EM.
 Represented the Environmental Monitoring Department in bi-weekly managers meeting and reported EM results. Reorganized Environmental Monitoring department in an effort to streamline program.
 Reviewed all data generated in Microbiology laboratory and report results/findings to appropriate departments. Worked with QA to resolve deviation reports and lead investigations on OOS EM results. Revised all EM SOPs and authored new SOPs as needed. Supervised reorganization of the new HIV production rooms and worked with QA and Facility departments to reduce contamination.
 Authored rough draft of HIV RNA process for RNA Manufacturing group for IND submission to the FDA. Reduced cost of consumables by researching alternative vendors. Responsible for recruiting/shipping to outside laboratories for microbial and yeast/mold testing Tested new cleaning methods from outside vendors and reported results Held training classes for employees on new EM policies for RCC and HIV facilities Skill Set: Project Management , cGMP, Technical writing, Microbiology, Leadership, Vendor Liaison, OOS deviation investigations,Review of EM results New SOP and item spec authorship and revision to existing documents,Held training classes for EM policies and procedures.
  3. 3. Production Associate III Argos Therapeutics Durham, NC January 2004 – April 2006 Summary I worked on an autologous cellular immunotherapy for individuals with Renal Cell Carcinoma and HIV. During my tenure, I had the opportunity to focus on and cross-train in manufacturing, Quality Control, Research and Development and the Process Development departments. Responsibilities Worked closely with Research and Development and Process Development departments with tech transfer to Manufacturing for upcoming clinical trials. Contributing authorto the RNA purification production section of DMF. Authored over 15 new MasterBatch Records and revised existing MBRs as needed. Lead RNA team meetings when necessary and planned production schedule Authored numerous Item Specs and procured CoA's as necessary Assisted with the training of new employees and ensured that all training documentation was complete and current. Skill set: RNA column purification/mini and maxi column, Spectrophotometry, Aseptic technique,Technical writing, Schedule planning, Team leadership, Production planning Duke University Medical Center Department of Neurology Durham, NC March 2002 – December 2003 Assisted Primary Investigatorin Alzheimer’s Disease (AD) research. Studied Nitric Oxide (NO) as a protecting factor against the progression of AD. Responsible for the proliferation and treatment of human clonal cell lines with NO stimulating factors,and quantifying NO production and protein content of the cell lines. Education 1995- 1999 North Carolina State University BS, Biological Sciences Senior Internship: Syngenta (formerly Novartis). I was subsequently hired after graduation as a research assistant.