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quality control manager resume example with 20+ years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
Professional Overview

Over 10 years experience in the Contract Research organization and Pharmaceutical/Biotech industries managing QC testing for a wide variety of products from medical devices, small and large molecule and inhaled pharmaceutical products. I have held positions of increasing responsibility at two CRO's, a clinical manufacturing plant and most recently at a contract manufacturing organization as the Quality Control Manager with responsibilities for all aspects of quality control for the manufacture of biopharmaceutical products.

Education
University of Illinois at Chicago Chicago, IL Expected in 2000 Bachelor of Science : Biological Sciences with a Minor in Chemistry - GPA :
Experience
Honeywell - Quality Control Manager
Spokane, WA, 08/2011 - Current

Responsible for the Quality Control Department at a Phase 1/2 contract manufacturing organization

  • Managed Quality Control lab relocation and expansion to a new facility
  • Manage the QC department daily activities including: In-process and Lot Release Sample analysis, Stability Studies, and Inspection and testing of Raw Materials
  • Manage all client correspondence from project initiation to site audits
  • Support development of novel QC analytical methods working with the analytical development department
  • Manage Quality Control operations to validate and support the manufacturing facility's HVAC system, Gas supply, Purified Water and WFI systems
  • Manage Quality Control equipment validation, calibration and maintenance activities
  • Member of the site Validation Team
  • Write, edit, review, approve and implement site Standard Operation Procedures (SOPs)
  • Write, review, approve and implement product specifications raw material specifications
  • Review and approve Quality Control Laboratory records including environmental monitoring, deviations, corrections, change controls, OOS and lab investigations
  • Support laboratory with 5S implementation and site safety audits
  • Site manager for all outsource testing, responsible for managing contracts, shipments, testing and special projects
  • Manage Quality Control budget and responsible for implementing cost savings within the department
B. Braun Medical Inc. - Supervisor II, Quality Control
Minneapolis, MN, 04/2008 - 08/2011

Responsible for the Quality Control program for Phase 3 clinical manufacturing for a lyophilized parenteral

  • Site Quality Program Supervisor and project manager; managed Quality Control staff and several contract research organizations; responsible for the Quality Control Budget
  • Site QC lead working with Fill/Finish CMOs as well as CTOs to develop and execute analytical assays
  • Member of the Mentor Management team, CMC team, Material Review Board and Safety Committee
  • Managed the CMC Analytical Team for Method Execution as the Team Lead
  • Implemented and managed the Analytical Reference Material program
  • Worked closely with the Operations and Quality Teams on site and off site within the JnJ companies to improve the internal Quality Control Systems
  • Managed all Out of Specification (OOS) investigations, Deviations, CAPAs and Change Controls per GMP procedures
  • Managed the scheduling for cleaning and environmental monitoring for ISO 7/8 manufacturing suites
  • Managed the manufacturing QC testing for the API, Bulk Drug Substance, Drug Product in-process, release and Stability testing program
  • Managed the utility and in-coming raw material testing program
  • Responsible for writing SOP's, Stability protocols, Test Methods, and Stability and utility trending reports
  • Responsible for sample management and all shipments for high levels of botulinum neurotoxin
  • Assisted the Quality Assurance group by performing audits for external testing organizations

Department Of Agriculture - Associate Group Leader, Microbiology Quality Control
Camp Verde, AZ, 03/2005 - 04/2008

Responsible for the Quality Control Microbiology lab at a Contract Research Organization

  • Responsible for the method development, method validation, routine release and stability testing and scheduling for large and small molecule and inhaled pharmaceuticals
  • Implemented the start up plan for the internal Microbiology Laboratory
  • Implemented, scheduled and performed the following testing: Microbial Limits Testing and Qualification, Bacterial Endotoxin Testing, Microbial ID, Environmental Monitoring, Sterility testing and B/F
  • Wrote and executed equipment IOQ and performance qualifications during start up of the laboratory
  • Responsible for training and supervising 8 Micro analysts
  • Managed communication with multiple external and internal client projects for Microbiological testing of Pharmaceuticals
  • Member of the site safety committee

Creighton University - Auditor. Quality Assurance
Omaha, NE, 07/2002 - 03/2005
  • Responsible for auditing data generated for pharmaceutical drug products, API's, raw materials, method development and validations per cGMP's and ICH guidelines using approved methods and current USP/EP/JP/BP compendial methods
  • Managed data auditing for multiple client projects and achieved all time lines and project goals
  • Responsible for training all new employees for the company to ICH stability testing and sample management procedures during the initial training orientation
Northview Biosciences (SGS) - Microbiologist
City, STATE, 11/2001 - 07/2002

Responsible for performing sterility assurance testing on pharmaceutical and medical devices in a class 8 clean room at an ISO 9002 certified and FDA registered company

  • Responsible for maintaining clean rooms and various laboratories
  • Aided project leads with investigations of product contamination and identified isolated microorganisms
Illinois Institute Of Technology - Research Laboratory Technician
City, STATE, 2001 - 11/2001

Employed by the Illinois Institute of Technology, but supervised by FDA researchers located at the National Center for Food Safety and Technology

  • Responsible for research experiments using E.coli 0157:H7 and E.coli K12 inoculated in solutions to simulate commercial apple juice to determine the effectiveness of UV light to reduce product contamination
Additional Information
  • Excellent interpersonal skills enhanced with professional Leadership Training (Conflict Resolution, Teamwork, Problem Solving and Negotiation Skills)
  • Received site recognition awards for management achievements during two most recent positions
  • Certified in First Aid and CPR

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Resume Overview

School Attended

  • University of Illinois at Chicago

Job Titles Held:

  • Quality Control Manager
  • Supervisor II, Quality Control
  • Associate Group Leader, Microbiology Quality Control
  • Auditor. Quality Assurance
  • Microbiologist
  • Research Laboratory Technician

Degrees

  • Bachelor of Science

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