1. Donna Jenkins
2565 Mint Julep Drive
Creedmoor, NC 27522
919-339-8077 (c)
donna3jenkins@gmail.com
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. 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. 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.