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Pharmaceutical Quality Assurance/Human Resources Associate Resume Example

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PHARMACEUTICAL QUALITY ASSURANCE/HUMAN RESOURCES ASSOCIATE
Summary

Quality Assurance and Human Resources professional accomplished in creating and implementing standard operating procedures as well as employee on-boarding, training and development.

Highlights
  • Staff training and development

  • Discretion with confidential and proprietary information

  • Committed to Diversity and Inclusion

  • Excellent written and verbal communication

  • People-oriented

  • Proficient in Microsoft Office Suite
Accomplishments

Designed a Training Matrix to track training progress of entire staff, thus ensuring compliance with Federal Drug Administration regulations.


Executed review and revision of all Standard Operating Procedures to ensure compliance with federal guidelines, efficacy and clarity.


Oversaw a group of six interns and coworkers coordinating market research projects for each product for multiple product lines, as well as, multiple clients.


Acted as company liaison to regulatory officers during audits by the Federal Drug Administration.


Administered yearly cGMP (current Good Manufacturing Practices) and Diversity training.


Coordinated with multiple departments to produce Annual Product Reviews for each product on multiple lines for multiple clients.


Experience
Pharmaceutical Quality Assurance/Human Resources AssociateNov 2011 to Jul 2013
Company Name - City, State
  • Write Standard Operating Procedures and conduct training to ensure all employees are knowledgeable in current Good Manufacturing Procedures and Federal Drug Administration regulations.
  • Create and maintain a Training Matrix to ensure every employee is compliant with federal and corporate training guidelines.
  • Oversee completion of New Hire paperwork and on-boarding materials.
  • Managed personnel files according to policy and federal and state regulations.
  • Assist Senior Vice President of Quality Assurance and Regulatory Affairs with talent acquisition, internal audits and product release/disposition.
  • Create and update new product listings for electronic submissions to the Federal Drug Administration.
  • Review manufacturing data documentation for Quality Assurance.
  • Investigate and follow up on non-conformances, deviations, and complaints.
Child Care Oct 2009 to Aug 2011
Company Name - City, State
  • Care for two children ages 7 and 9, one child with special needs.
Pharmaceutical Quality Assurance Document ControllerJul 2006 to Oct 2009
Company Name - City, State
  • Write, revise and archive Standard Operating Procedures, protocols and reports per current Good Manufacturing Procedures and Federal Drug Administration regulations.
  • Prepare documents for audits by regulatory bodies, including the Federal Drug Administration.
  • Audit protocols, procedures, reports, and batch records for Quality Control, Research and Development, and Drug Manufacturing.
  • Participate in Quality Assurance audits of other departments to insure compliance with procedures.
  • Perform safety audits as part of the Site Safety Committee.
  • Track document revisions in a highly regulated environment.
Pharmaceutical Document Control Assistant/Project ClerkJun 2004 to Jul 2006
Company Name - City, State
  • Create, revise, and obsolete controlled documents per current Good Manufacturing Procedures and Federal Drug Administration regulations.
  • Track all documents through signature circulation per Standard Operating Procedure.
  • Receive and verify all samples submitted for laboratory analysis and track through analytical review stages.
  • Maintain laboratory analysis reports and product stability reports in a highly regulated work environment.
Education
BA, SociologyMay 13, 2011University of Georgia - City, StateGPA: GPA: 3.73

UGA Cumulative GPA: 3.73


Minor in Cultural Anthropology


Emphasis on Race, Gender and Class, as well as, Culture


University of Georgia's Ray Payne Award for the one student who excels in Sociology courses and performs beyond the expected coursework in a way that demonstrates a commitment to sociology and a great potential for professional development in the discipline.

Master of Arts, SociologyThe New School for Social Research - City, State

Pending

Research Experience

LaSSI Lab Research Assistant (Lab for the Study of Social Interaction)

Workplace Decision-Making Study

•Participant recruitment.

•Run participants through experiments and enter data.

Testing a Dynamic Theory of Social Emotions Using Infrared Imaging Study

•ANS coding.

The Social Structure of Tattoo Shops: A Study of Respect within Subcultures

•Observed participants in the field.

•Conducted one on one interviews with participants.

Skills

Documentation, Creation of protocols and standard operating procedures, Quality Assurance, Recruitment, Research, Confidentiality

Professional Affiliations

Member of Alpha Kappa Delta International Sociology Honor's Society


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Resume Overview

School Attended

  • University of Georgia
  • The New School for Social Research

Job Titles Held:

  • Pharmaceutical Quality Assurance/Human Resources Associate
  • Child Care
  • Pharmaceutical Quality Assurance Document Controller
  • Pharmaceutical Document Control Assistant/Project Clerk

Degrees

  • BA , Sociology May 13, 2011
    Master of Arts , Sociology

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