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Quality Assurance Management

Location:
Kennett Square, PA, 19348
Posted:
August 24, 2010

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Resume:

Sara Marie Burhans

** **** ******** *****

Kennett Square, PA 19348

Phone: 610-***-****

Email: abltpj@r.postjobfree.com

PROFESSIONAL PROFILE

Over seven years experience in the pharmaceutical / scientific industry.

Proven interpersonal, organizational, presentation and project management

skills, as well as the ability to communicate across all organizational

levels. Experienced in Microsoft Office Suite and familiar with many

advanced functions in Excel and Access. Possesses a solid advanced

educational foundation and a positive, outgoing and creative personality

that can lead and deliver results.

EDUCATION

Masters of Business Administration, Pennsylvania State University, 2007

. Biotechnology and Health Industry Management

Bachelor of Science in Business, Pennsylvania State University, 2003

. Marketing and Management, minor in Biochemistry and Molecular

Biology

. Delta Sigma Pi International Professional Business Fraternity

. Gamma Sigma Sigma National Service Sorority

WORK EXPERIENCE

Shire Pharmaceuticals

Quality Assurance Analyst - Clinical / Analytical GMP

Sept. 2006 - Present

. Review and release of master and executed batch records, raw

materials, clinical protocols, labels and analytical results for

intermediate and finished products to assure they are completed to US

and / or EU regulatory standards.

. Creation and management of related Quality Notifications and CAPA's

for deviations and investigations in SAP.

. Led investigations and resolved quality issues efficiently through

working closely with multiple branches of the organization involving

senior management, regulatory affairs, clinical development and

outside contractors.

. Reviewed investigational new drug applications for global product

submissions for accuracy of data compliance to US and international

regulatory standards.

. Managed clinical projects which resulted in the continual on time

release of materials for clinical trials.

. Conducted an audit of a clinical manufacturing organization involved

in primary and secondary packaging of clinical supplies for compliance

to regulatory standards.

. Developed an Excel based tracking system for tracking and management

of clinical documentation.

. Managed the development and maintenance of the clinical teams'

training requirements.

. Supported an overlay / internal audit project and effectively resolved

and identified potential issues relating to potential or current

violations of FDA regulatory standards.

. Wrote and edited standard operating procedures specific to clinical

operations.

. Evaluated Quality and Technical Agreements for clinical contract

manufacturing organizations to ensure they meet our needs and

objectives.

. Improved manufacturing and quality management processes through

investigations initiated from tracking and evaluating non-

conformances.

. Investigated and closed out all clinical complaints received for

previous and on going clinical trials while maintaining the

confidentiality of blinded trials.

AquaCap Pharmaceuticals Inc.

Quality Assurance Specialist July

2004 - July 2006

Formulation Manufacturing Associate

. Conducted and developed quality control procedures and internal audits

of batch records and other production logs to ensure GMP compliance.

. Approved and quarantined raw materials and components received from

external suppliers.

. Designed and implemented a system to track and store retained samples.

. Developed technical training programs for new manufacturing

associates.

. Created production batches for use in manufacturing processes.

. Supervised the operation of encapsulation machinery for the

pharmaceutical / nutritional supplement production line.

AppTec Inc.

Microbiology/Environmental Technician

March 2004 - July 2004

. Conducted sampling and testing of air (active and passive sampling),

surfaces (contact plates, swab samples), water, gases, solutions,

chemicals, materials and personnel for microbial contamination.

. Preparation and revision of standard operating procedures and batch

records in compliance with GLP and GMP standards.

. Conducted of quality control procedures.

. Operation of state of the art machinery (Air Particle Counter (APC) -

for non-viable air collection, RCS - for viable air collection) for

parameter collection.

FirstEnergy

Budget Analyst Intern June

2003 - Dec. 2003

May 2002 - Aug.

2002

. Development of base line data that utilized in the preparation of the

2003 - 2004 budget.

. Identification and analysis of historical and current spending trends.

. Creation and management of large databases for budget related

information.

. Preparation of ad hoc reports for various budget related requests.

AstraZeneca Pharmaceuticals

Intern in Behavioral Pharmacology

May 2001 - Aug. 2001

Intern in NeuroPharmacology May

2000 - Aug. 2000

. Contributed to ongoing drug research projects through daily

involvement in behavioral trials and data management and analysis.

. Preparation and presentation of materials (presentations, scientific

posters etc,) for various scientific meetings.

. Designed and conducted laboratory experiments to test for various

desired results.

. Operated state of the art machinery (Oxyphase - for micro vascular

measurement, and Mi2 - for physiological parameter collection) to

collect relevant specific data.

SKILLS

. Experienced in Microsoft Office Suite, Microsoft Project, SAP,

CLINapps, Trackwise, Visual Basic, and Oracle.

. Excellent communication and written skill sets (experienced in

technical writing).

. Thorough knowledge of cGMP and GLP regulations and a working knowledge

of European regulations.

PUBLICATIONS

. See attached sheet.

MEMBERSHIPS

. The Parenteral Drug Association (PDA)

PUBLICATION CITATIONS

Contributor: chapter author, editor, and researcher.

Hammaker, D. K. (March 17, 2010). Health care management and the law:

Principles and applications. Clifton Heights, NY: Thomson Reuters,

Delmar Cengage (ISBN: 978**********; ISBN: 142*******).

___ Study guide for Hammaker's Health care management and the law:

Principles and Applications. Clifton Heights, NY: Thomson Reuters,

Delmar Cengage (ISBN: 978**********; ISBN: 142*******).

___ Electronic classroom manager for Hammaker's Health care management and

the law: Principles and Applications. Clifton Heights, NY: Thomson

Reuters, Delmar Cengage (ISBN: 978**********; ISBN: 142*******)

(instructor's resource to accompany the textbook).

___ (November 2010) Essentials of Health Care Management and the Law.

Clifton Heights, NY: Thomson Reuters, Delmar Cengage.

___ & Knadig, T. M. (TBP 2011). Health care ethics and the law: Principles

and applications. Clifton Heights, NY: Thomson Reuters, Delmar Cengage.

___ (TBP 2011). Nursing care management and the law: Principles and

applications. Clifton Heights, NY: Thomson Reuters, Delmar Cengage.

___ (TBP 2012). Dental care management and the law: Principles and

applications. Clifton Heights, NY: Thomson Reuters, Delmar Cengage.



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