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location: Lake Zurich, Illinois
job type: Contract
salary: $25.00 - 29.50 per hour
work hours: 9 to 5
- 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.
- 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.