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Software Quality Assurance - C2C/W2


Job Id : 7953

Jobtitle : Software Quality Assurance - C2C/W2

Location : Sunnyvale, CA

Company Name : Thoughtwave Software And Solutions

Industry : Information Technology

Salary : $59,000 - $73,000  YEAR

Job type : Contractor

Posted on: 2019-11-27


Required Skills : QA, Auditor, Interpersonal Skills, Problem Solving Skills, GMP

Benefits : No benefits are available


Job Description:

 

  • Independently performs routine Document Control activities, including, but not limited to: Process DCR packages and review for accuracy and completeness; manage in-process DCRs; create/generate moderately complex reports; issue and manage QA controlled lab notebooks and logbooks
  • Independently facilitate the Document Request process including providing formatting, coordinating the review and approval process, tracking and routing controlled documents
  • Perform administrative tasks to maintain the electronic document management system (EDMS), including collaborating with Document Control management to address/remediate process and EMDS issues ,and also support system updates/upgrades
  • Provide user assistance and training on document control and record management systems, processes, and procedures
  • Perform Document Control EDMS training for new employees
  • Perform duties in support of established records management procedures for paper and electronic records, including management of the on-site document vault and offsite records storage and retrieval
  • Manage and maintain the archival of master documents and records (both hardcopy and electronic) such that required documentation is retrievable and files are accurate, complete and well organized.
  • Prepare document control metrics and reports
  • Provide support for audits and regulatory agency inspections
  • Manage/participate in projects/assignments that support continuous improvement efforts and department and goals as assigned by Quality Management.
  • Represent Document Control in project and functional meetings
  • Provide general support for the overall Quality System
  • Initiate and revise applicable Document Control SOPs and Work Instructions, as required

 

Experience:

  • 2-5 years of pharmaceutical experience in a GMP environment administering Document Control Systems
  • 2 years' experience using and administering electronic document management tools
  • Working knowledge of Quality Systems, GMP-related requirements and ICH guidelines, desirable
  • Working knowledge of electronic documentation systems, data retrieval, and electronic file formats
  • Detail oriented with solid problem-solving acumen
  • Ability to work effectively in a team environment
  • Ability to analyze and reconcile moderately complex issues
  • Must have demonstrated initiative and accountability in a fast-paced environment
  • Must demonstrate leadership skills through example
  • Excellent verbal and written communication and interpersonal skills
  • Proficient with computers and word processing software (i.e. Microsoft Office products).

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