Octapharma Plasma, Inc.

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Requisition Number 18-3282
Post Date 9/17/2018
Title Quality Systems Associate
City Charlotte
State NC
Position Type full-time
Description
  • Develop, implement, and manage automated Quality Systems.  Supports Validation, as needed.  
  • Developing and maintaining project plans for automation of Quality Systems. Coordinating multiple projects at the same time.
  • Leading cross-functional teams to develop and implement process improvements by challenging MasterControl (MC) and other system capabilities to meet business needs.
  • Recommending solutions to practical problems with consideration for company, customer and regulatory requirements.
  • Recommending solutions for process improvement plans and drive projects to implementation.
  • Developing/revising standard operating procedures (SOPs) and reports for automated processes.
  • Participating on the Validation Team to develop the Validation Test Plan, assess risks, generate test cases, and execute Validation Test Cases.
  • Collaborate with the Validation Team to provide all required documents to ensure the Quality System is validated and maintained under the company’s change control process.
  • Collaborating with the Training Department to generate materials that train end-users on automated Quality Systems.
  • Work cohesively with IT business analysts, end users, and other stakeholders to review user/functional requirements, risk assessments, and validation plans in order to recommend revisions or changes in scope, format, content, and methods of validation execution.
  • Review completed validation documentation to ensure actual results match expected results and all deviations that occur during the validation process are resolved appropriately.
  • Provide support during internal/external audits and regulatory inspections.
Requirements
  • A bachelor’s degree in an IT-related field or allied health sciences (chemistry, biology) with two (2) years’ experience in an FDA-regulated environment. 
  • Intermediate-level experience with Microsoft Office.  
  • Experience with Visio and project management software preferred.
  • Experience with a document management software preferred.
  • Ability to critically review and revise documents/processes.
  • Ability to work independently assuming leading roles.
  • Ability to simultaneously organize and manage multiple projects.
  • Excellent verbal and written communication skills.
  • Ability to facilitate meetings with peers, managers, directors and senior management.
  • Must be detail-oriented, possess excellent time management skills, be well organized and have an ability to work well independently.
  • Ability to facilitate meetings and execute training presentations with peers, managers, directors and senior management.

PHYSICAL REQUIREMENTS:

  1. Ability to view video display terminal images eighteen inches away from face for extended periods – up to four (4) hours at a time.
  2. Ability to sit for extended periods – up to six (6) hours at a time.
  3. Ability to lift, tug, and pull boxes up to ten (10) pounds.
  4. Physical ability to operate computer keyboard and telephone.
  5. Ability to travel via automobile and/or plane, when applicable.

 

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