Quality Systems Administration resource I

  • location: Northbrook, IL
  • type: Contract
  • salary: $31.59 - $37.16 per hour
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job description

Quality Systems Administration resource I

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We are currently partnering with a company known for their leading clinical trials as well as Research & Development. With the goal to constantly develop innovative products, you will feel secure in the fact that you are making a difference. Apply for your dream job now!

 
location: Northbrook, Illinois
job type: Contract
salary: $31.59 - 37.16 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Function as the Quality Document (QD) Administrator responsible for reviewing new or revised Quality Documents for compliance to established standards.
  • Ensure all Quality Documents meet required standards before processing documents in the company Document Management System - Quality Document (ADMS QD) workflows.
  • Ensure impacted stakeholders are involved in the review of new and revised Quality Documents.
  • Deliver effective communication of requirements and standards to Authors of Quality Documents as well as to the Users of the company Document Management System - Quality Document (ADMS QD).
  • Support the development, review and delivery of training materials to provide to new users of the ADMS QD system.
  • Provide guidance on proper methods for writing SOPs and other Quality Documents to meet standards.
  • Support Document Control initiatives that lead to process improvements.
  • Respond to email inquiries and user support questions.
  • Support ADMS QD users on document retrieval for superseded and obsolete documents as well as completing requests for uploading documents into the ADMS QD Repository.
  • Functions as the CRQA point of contact for all functional areas utilizing the M&D Quality Management System.
  • Supports the CRQA staff of approximately 70 individuals, by offering consultation, advice, and subject matter expertise regarding QMS document control requirements. Processes and manages approximately 125 quality documents per month.
  • Reports to the Associate Director, Quality Systems Document Control & Administration.
  • No people management responsibilities
  • Collaborates directly with CRQA Leadership Team, CRQA staff, and various levels within Medical and Development (M&D) functions including functions outside of M&D that utilize ADMS QD.
 
qualifications:
  • Bachelor of Arts/ Bachelor of Science degree BS/BA.
  • 2 - 5 years working experience in the pharmaceutical industry, one of which should be within Quality Assurance and/or within SOP writing, Process Improvement or similar discipline.
  • Proficiency in Microsoft Office.
  • Strong interpersonal skills and multi-cultural /intercultural awareness, able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration.
  • Excellent oral and written communication.
  • Ability to work independently, multitask and shift workload according to department/team priorities.
  • Strong planning and organizational skills and experience managing multiple priorities simultaneously.
  • Working knowledge of Microsoft Office tools (e.g., Word, Excel, PowerPoint) and PDF editor software (e.g., Adobe Professional, Foxit).
  • High attention to detail.
Preferred

  • Experience processing documents for review and approval using an electronic system.
 
skills: SOP, Quality Assurance, MS-WORD, MS-EXCEL, MS-Powerpoint
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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