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Manager, Document Management (Quality Systems) Resume Example

Resume Score: 90%

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MANAGER, DOCUMENT MANAGEMENT (QUALITY SYSTEMS)
Executive Summary

Reliable and disciplined Human Resources professional with more than 14 years combined HR/Quality experience in the Pharmaceutical manufacturing and Biotech industries. Flexible, driven by details, and able to manage competing priorities in a fast-paced environment.

Core Competencies
  • Employee Relations
  • Compensation & Benefits Administration
  • Payroll
  • Mergers & Acquisitions
  • HRIS
  • Training & Development
  • Employee Retention
  • Recruiting
Professional Experience
Manager, Document Management (Quality Systems)07/2012 to CurrentSandoz Inc.Broomfield, CO

Oversee the management and development of a Document Management team (5 full-time employees); responsible for full life-cycle master control of 10,000+ GxP documents in a solid-dosage form pharmaceutical manufacturing facility

  • Led cross-divisional project for new GMP Part 11 compliant Electronic Document Management (EDM) system - URS definition, functional specification development, validation, migration, training, user access management, 24/7 help desk support
  • Quality review/approval of packaging finished product labeling - labels, SPL, outserts/inserts, packaging
  • Master batch record issuance of manufacturing and packaging records
  • Archiving activities - records retention, product litigation review, document destruction
  • Weekly/ monthly metrics and KPI reporting
  • Assistant auditor to support internal audit program
  • Support regulatory and supplier quality inspections and audits
  • Addt'l Quality Systems support: Change Control (CCR), CAPA, Annual Product Reviews (APR)
Supervisor, Document Management08/2010 to 07/2012Sandoz Inc.Broomfield, CO

See Manager, Document Management position above

Sr. HR Generalist11/2009 to 08/2010Sandoz Inc.Broomfield, CO

Provided comprehensive site HR support to Quality Assurance, Quality Control, Technical Services, Engineering, Internal/External Supply Chain, Procurement and Distribution/Warehouse organizations.

  • Maintained multiple database systems - People Soft, Pathfinder, Brass Ring
  • Provided employee relations support in accordance with all applicable federal, state, and local laws
  • Developed and led New Employee Orientation (NEO) program
  • Assisted in the development of comprehensive on-boarding process, implemented for all US locations
  • Directly recruited 45+ science/engineering positions and 4 director-level positions in 2009 & 2010
  • Initiated local college recruiting program - participated in speaking engagements at local colleges/science clubs to educate on industry options for science majors
  • Company representative for state unemployment hearings
  • Facilitated employee trainings - Performance Management, Objective Setting, New Employee Orientation
  • Member of site Emergency Response and Chemical Spill team
HR Generalist III10/2007 to 10/2009Sandoz, Inc.Broomfield, CO

See Sr. HR Generalist position above

Manager, Human Resources03/2005 to 10/2007ThermoFisher Scientific (formerly Dharmacon Inc.)Lafayette, CO

Provided comprehensive HR support for division corporate office and manufacturing site (siRNA)

  • Managed HR team of three - HR Generalist, Corporate Recruiter, Front Desk Administrator
  • Led employees through two mergers/acquisitions
  • Process Control Champion for company-wide Practical Process Improvement program
  • Developed Employee Bonus Incentive Plan for manufacturing division
  • Implemented company compensation banding and career track banding
  • Implemented new HRIS and payroll system
  • Implemented new 401(K) Plan
  • Created and maintained employee materials including handbook, policies, and procedures
  • Maintained and submitted weekly, monthly, and quarterly cross-functional reports
  • Created system to ensure HR document retention was in accordance to all federal, state, and local regulations
  • Administered payroll for local workforce and multi-state sales employees
  • Conductedweekly new hire orientations and facility tours
  • Specialized in the administration of health and welfare benefits
  • Developed the ACE Award program, an employee recognition program
Sr. Human Resources Generalist02/2003 to 03/2005ThermoFisher Scientific (formerly Dharmacon Inc.)Lafayette, CO

See HR Manager position above

Research Associate05/2002 to 02/2003Dharmacon Inc.Lafayette, CO
  • Established the Laboratory Support department - authored standard operating procedures (SOP's) and manuals required for the production and attainment of buffers, reagents, purification gels, and all production supporting materials
  • Manufactured and tested siRNA utilizing synthesizers, HPLC, Mass Spec
  • Modification of siRNA orders - gel electrophoresis purification, column purification, duplexing, deprotecting
Education
Associate of Arts: Biological Sciences2002University of DenverDenver, CO, United States

GPA - 3.86

Minor - General Business

Skills

ADP (payroll processing), Brassring (applicant management system), Microsoft Office Suite (Word, Excel, PowerPoint, Visio, SharePoint, Access), NextDocs (SharePoint EDMS), Pathlore (LMS), Paychex (payroll management), PeopleSoft (HRIS), SAP, SELS (LMS), TrackWise (quality management)

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Resume Overview

Companies Worked For:

  • Sandoz Inc.
  • Sandoz, Inc.
  • ThermoFisher Scientific (formerly Dharmacon Inc.)
  • Dharmacon Inc.

School Attended

  • University of Denver

Job Titles Held:

  • Manager, Document Management (Quality Systems)
  • Supervisor, Document Management
  • Sr. HR Generalist
  • HR Generalist III
  • Manager, Human Resources
  • Sr. Human Resources Generalist
  • Research Associate

Degrees

  • Associate of Arts : Biological Sciences 2002

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