MONICA J.

BRUCKNER 9599 Quarry Bridge Court, Columbia, MD 21046

(314) 956-7262 mb7f891c@westpost.n
et
OBJECTIVE
To obtain a challenging position in quality assurance/quality control with ad
vancement opportunities.
PROFESSIONAL EXPERIENCE
Quality Assurance/Quality Control Manager, 2009-present, New Horizons Diagnosti
cs Corp., Columbia, Maryland
Responsibilities include establishing, maintaining, and updating the NHD Quality
System and regulatory compliance. Implementation of cGMP processes as they rela
te to quality planning, documentation approval, design controls, corrective and
preventative actions, complaint handling, facility maintenance, auditing, traini
ng, testing and validation. Assisting in writing 510(k) submissions and represen
ting management to the FDA and other regulatory agencies. Supervise laboratory t
echnical staff and production personnel.
* Part of a research group investigating the use of enzymes and antibodies for t
herapeutic applications
* Part of a design team that is continuing to develop reagents and instrumentati
on for the rapid detection of living bacteria and spores in water, fuel, food, a
ir, and on surfaces using bioluminescence.
* Responsible for developing and approving product labels including package inse
rts and manuals.
* Ensure management review of Quality System, implementation of corrective and p
reventative actions, and follow-up to complaints and failure investigations.
* Established and and continue to maintain training programs, including document
ation of the training, for cGMP and cGLP, safety, job-specific tasks, internal
auditing, and documentation writing.
* Initiate, write, and review new and existing quality assurance and quality con
trol documentation including SOPs, SMPs, and STPs.
* Serve as team leader for both internal, vendor, and regulatory audits, includi
ng 3/2010 FDA site inspection.
* Ensure the proper maintenance, certification, and calibration of biological sa
fety cabinets, chemical fume hoods, pH meters, balances, and various other piece
s of laboratory equipment.
* Responsible for overseeing environmental controls and water system testing and
maintenance.
* Develop and perform validations on manufacturing processes and laboratory equi
pment.
* Validated and currently monitor shelf-life dating and storage conditions for s
everal NHD products.
* Organize, receive, and validate QA/QC testing panels for NHD diagnostic produc
ts including select agents.
* Maintain control of incoming raw materials and of outgoing materials, includin
g final inspections of components and kits prior to shipment and label control.
Cashier and Meat Wrapper, 2008-2009, Costco Wholesale Warehouse, Columbia, Maryl
and
* Work as a member of a team to ensure speed and accuracy of customer checkout
* Promote Costco's goals and values through positive customer interaction and ha
rd work
* Learn all relevant equipment operations including the cash registers, scanners
, and meat wrapper
Sales Advisor, 2008, Club Demonstration Services, Inc., Columbia, Maryland
* Demonstrate products as directed by vendors to increase sales of these product
s in Costco Warehouses
* Meet and exceed sales goals and give excellent customer service
* Work as a member of a team to prepare for and clean up from the days demonstra
tions
American Red Cross National Testing Laboratory, St. Louis, Missouri
Lead Laboratory Technician, Viral Laboratory, 1997-2002
* Performed and supervised the performance of STP's to assure the safety, potenc
y, and purity of the national blood supply including final operational review of
testing records and laboratory maintenance sheets.
* Assured compliance with standard operating procedures, CFRs, FDA and OSHA regu
lations, and all other applicable state and federal laws.
* Responsible for scheduling, troubleshooting, training of staff, and supply and
reagent management.
* Learned all maintenance and troubleshooting for most lab equipment to ensure t
he least amount of lost time from equipment malfunction.
* Directed work flow to maximize production and minimize errors.
* Performed quality control protocols to identify irregularities, investigated t
o determine the root cause, and then worked to determine the solution to resolve
the problem.
* Used quality assurance directives, reviewed records to assure accurate record
keeping, performed internal audits, and identified discrepancies in those record
s.
* Completed Frontline Leadership, Personnel Practices, CPR and First Aid, Curren
t Good Manufacturing Practices for Management, and Preceptor and Instructor Cert
ifications.
* Originated, investigated, and implemented change control procedures to constan
tly improve existing and new ideas and SOPs.
* Interacted positively and successfully with many different departments and shi
fts to facilitate goals of the department and the company as a whole.
* Participated in customer contacts and problem resolution.
* Used multiple word processing and spreadsheet applications to facilitate daily
tasks.
* Performed other duties as assigned including lab week planning and other team
building activities.
Laboratory Technician, Viral Laboratory, 1995-1997
* Performed automated and manual enzyme immunoassay testing on samples while adh
ering to quality assurance protocols and good manufacturing practices.
* Participated in quality control and in-process review to ensure valid testing
results.

Veterans Administration, St. Louis, Missouri, Clinical Research Assistant, 1991-

1993
* Assisted principle investigator in conducting gastrointestinal research studie
s on spinal cord injured veterans
* Assisted investigators in statistical analysis and tracking of data.
* Conducted and supervised patient testing, researching, and writing grants and
publications.
* Recruited subjects and interacted with a wide variety of medical and administr
ative personnel.
National Institute of Drug Abuse, Baltimore, MD, Research Assistant, 1989-1991
* Assisted in animal and human research relating to drug use and abuse.
* Included animal care and surgery, publication reviews and research, blood gluc
ose and blood gas testing, and basic chemical analysis and pH determinations of
samples.
* Managed purchasing and accounting for entire lab.
* Responsible for compliance and training of safety practices for all personnel,
including OSHA regulations relating to biohazards, radioactive compounds and wa
ste, and chemical use and storage.
ACADEMIC EXPERIENCE
M.S., Neuroscience, Washington University School of Medicine, St. Louis, Missour
i, 1993
B.S. with Presidential Honors, Biological Science, Carnegie Mellon, Pittsburgh,
PA 1989
Extensive courses in horticulture, landscaping, and gardening, 1985-2008
MEMBERSHIPS
Florissant Garden Club 2005-2008, North County Perennial Exchange
U.C.W.D.C. 1993-2010
Swing Dance America, 1994-2010