Experience:
1-3 years of experience
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Employment Type:
Full time
Posted:
8/31/2018
Job Category:
Engineering
Industry:
Other
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Quality Systems Associate
Octapharma Plasma, Inc. | Charlotte, North Carolina
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Job 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.
  • 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.

 

About Octapharma Plasma, Inc.

We believe the growth and success of each of our employees is an important part of the continued growth and success of our company. We create a workplace known for teamwork and recognition based on the following values: Customer Focus Leadership Integrity Team Spirit Self Respect Respect for Others Life Balance Safety

This company profile was created by AfterCollege and is about Octapharma Plasma, Inc.. This page is not endorsed by or affiliated with Octapharma Plasma, Inc.. For questions regarding company profiles, please email: care@aftercollege.com.