QA Specialist

  • location: Lake Zurich, IL
  • type: Contract
  • salary: $25 - $29.50 per hour
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job description

QA Specialist

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 supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!
 
location: Lake Zurich, Illinois
job type: Contract
salary: $25.00 - 29.50 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Verifies compliance of all cGMP documents and data processed including, but not limited to, the document types of electronic Change Notices, paper-based Document Change Notices, Policies, SOPs, Specifications, Methods of Analysis and Protocols.
  • Coordinates and issues Document Change Notices (DCNs) associated with GO NAM sites, Packaging & Development, Regulatory Affairs, Contract Manufacturing, Innovation & Development and Sales & Marketing.
  • Ensures on-time review and approval processing of cGMP documents.
  • Generates and distributes monthly metrics reporting on the status of Change Notices routing for review and approval.
  • Performs weekly follow up of Change Notices to ensure processing towards completion.
  • Generates and distributes monthly metrics reporting on the status of 36-month document reviews of Policies and SOPs to facilitate compliant processing.
  • Distributes timely notifications to NAM locations on the publication of Global Quality Management documents.
  • Administers NAM procedure compliance assessments on the publication of Global Quality Management documents to ensure assessments evaluate global processes against local processes.
  • Serves as back-up Documentation Coordinator to the Regional GO NAM.
  • Maintains documentation archives to ensure documents are orderly, complete, accurate and readily available for inspection.
 
qualifications:
  • Bachelor of Science/Bachelor of Arts degree or equivalent work experience required, with a minimum of 3 years of QA experience in the pharmaceutical or related industry.
  • Working knowledge of GMPs and related Quality System processes is required.
  • Experience with Documentum Electronic Document Management System (EDMS) is required.
  • Quality Management module.
  • Position requires individual with high degree of accuracy. Must be able to translate theoretical knowledge into practical application.
  • Good oral communicational and interpersonal skills is required.
  • Good organizational skills is required.
  • Previous pharmaceutical industry experience is desirable (QC/QA/Regulatory).
  • Working knowledge of automated record keeping/retrieval systems is desirable.
  • Working knowledge in the software applications of Microsoft Excel and Microsoft Word.
 
skills: SOP, Quality Assurance, GMP (Good Manufacturing Practice)
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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