Project Manager Quality Assurance
Resume:
DEVORALYN KRISCHELLE BRANDON, CQE
Email: ***********@*****.***
**** ********* **** ***** ************, VA 23832
PROFESSIONAL PROFILE
American Society for Quality Certified Quality Engineer trained in Lean Six
Sigma Green Belt tools. Graduate with a B.S. degree in chemical engineering
with a record of success in quality and technical roles in the
pharmaceutical and medical device industry. Highly motivated individual
who strives on new challenges and has a strong work ethic. Effective
communicator with well-developed presentation skills. Ability to work well
independently as well as in a team while achieving personal and
organizational goals.
EXPERIENCE
Quality Engineer, Quality Control 2004 - 2010
Church & Dwight Virginia Co., Inc, Colonial Heights, VA
. Effective Project Manager. Acted as Project Manager for two Green
Belt Projects (waste reduction, process improvement) that resulted in
an annual cost savings of $60,000.
. Possesses strong problem solving and analytical skills used for
identifying and resolving problems and implementing corrective action.
Knowledge of quality tools and methodologies including DOE, FMEA, and
statistical process control.
. Responsible for maintaining the validation program - developing and
executing process, equipment, and software validation (IQ, OQ, PQ).
. Innovative. Recognized as the point of contact for protocol
development and execution. Developed the initial cartoning machine
qualification for the plant and initial software qualifications for
laboratory equipment.
. Responsible for continual improvement activities to enhance the
quality system, such as 5S, and Lean methods, etc. Responsible for
supporting Six Sigma implementation at plant - communicated
implementation plan to plant and corporate personnel.
. Excellent collaboration skills. Assisted Quality manager in
establishing, implementing and maintaining the quality management
system. Interfaced with Engineering and Operations to ensure transfer
to Production of new products are in accordance with approved data.
Coordinated and executed Research and Development trials for new
products.
. Experienced in Microsoft Excel, Word applications, and statistical
analysis program (Minitab).
Validation Engineer, Validation 2002 -
2004
Alpharma USPD, Baltimore, MD
. Competently executed and documented validation protocols for
facilities, HCVAC (heating, cooling, ventilation, and air
conditioning) systems, manufacturing equipment and laboratory
equipment used in liquid pharmaceutical manufacturing processes and
laboratory testing.
. Determined the disposition of validation activities, stating
requirements for completion and/or revalidation with regard to the
approved Site Validation Master Plan.
. Exhibits initiative, self-motivation, and self-discipline. Organized
and maintained a tracking system for validation protocols. System
tracks status of incomplete/complete protocols, their location, and
the instruments involved in each.
. Interfaced with regulatory agencies in support of validation actives
as needed. Selected by QSCAP (Quality Systems Corrective Action Plan)
committee to participate in regulatory inspection.
. Demonstrated outstanding leadership ability. Acted as back up to the
Validation Supervisor. Administered departmental and procedural
training. Wrote, reviewed, and approved validation procedures.
. Known for possessing a strong work ethic and being detail oriented.
Selected by management to assist chemistry laboratory auditors with
reviewing backlogged laboratory data.
. Served as a technical resource for reengineering Operation for process
capability and validation requirements. Provided input and response to
process deviations that require validation work for resolution.
. Key contributor in start-up of Nasal Spray facility. Determined the
required content of pre-validation engineering studies that will
support successful validation upon project implementation. Supervised
the activities of validation technicians and contractors.
Validation Engineer, Validation/Technical Services
2001 - 2002
Barr Laboratories, Forest, VA
. Responsible for execution and documentation of validation protocols
for new product, scale-up, and alternate site process validation for
solid-dose pharmaceuticals to ensure cGMP requirements for validation
are met and maintained over time.
. Proven ability in the area of technical writing. Skillfully wrote
technical reports to analyze data associated with laboratory and
validation test results and presented information to other
departments.
. Efficiently provided technical and organizational leadership for the
implementation of validation activities. Provided direction to project
team members in the validation approach/strategy and serve as a
knowledge base for validation and compliance best practices.
. Ability to effectively communicate with individuals at all levels to
accomplish organizational goals. Developed and maintained a positive
working relationship with Operations, Research and Development, and
Quality Assurance for introduction to new projects and maintenance of
existing processes.
. Possesses knowledge to question proposed changes, while evaluating the
effect on product quality. Competently applied troubleshooting skills
and recommended solutions to procedural and process problems as
appropriate.
. Excellent knowledge of regulatory requirements/ guideline in the area
of validation. Working knowledge of DEA (Drug Enforcement Agency)
regulations regarding controlled substance drugs.
Senior Site Compliance Auditor, Biological Quality Assurance
1999- 2001
Merck & Company, Inc., West Point, PA
. Established expertise in QA/QC (Quality Assurance/Quality Control) and
cGMP (current Good Manufacturing Practices) for compliance activities.
. Ability to prioritize multiple tasks and strive on new challenges.
Skillfully managed several leadership positions within the department
that included Internal Audit Coordinator, Adverse Experience
Coordinator and Vaccine Quality Council Coordinator.
. Administered, maintained and executed the QA Compliance audit program
as per the published schedule with complete audits, timely reports,
internal/external audit communications and audit follow-up and follow-
through.
. Conducted cGMP inspections in all vaccine operation areas, sterility
laboratory, chemistry laboratory, and microbiology laboratory.
Identified and communicated opportunities for process improvement
based on inspection observations.
. Exhibited excellent attention to detail. Responsible for the review
and approval of Standard Operating Procedures, validation protocols,
batch records and documentation change requests to ensure regulatory
compliance.
. Effectively provided support during Regulatory Agency Inspections by
hosting inspections, providing necessary documentation to agency
representatives and assisting with facility tours. Participated in
Federal Drug Administration inspections by Team Biologics, and
international regulatory agency inspections.
Vaccine Technology & Engineering Intern Summer 1998
Merck & Company, Inc., West Point, PA
. Excellent oral communication skills. Presented data analysis of
stability tests to representatives of various departments to determine
storage conditions for culture media.
. Successfully created a user-friendly interface system in which new
information can be inserted without difficulty in order to accommodate
future culture media stability test data.
Manufacturing Project Team Intern Summer 1996
and 1997
Merck & Company, Inc., Wilson, NC
. Created a detailed implementation schedule that effectively described
the procedure for manufacturing a new product at a plant site.
. Assisted in new product implementation. Duties included evaluating
and implementing new equipment, and providing support for engineering
trial runs.
EDUCATION: North Carolina A&T State University, Greensboro, North
Carolina
Bachelor of Science, Chemical Engineering, May 1999, Cum Laude
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