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location: Northbrook, Illinois
job type: Contract
salary: $31.59 - 37.16 per hour
work hours: 9 to 5
- 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- Support ADMS QD users on document retrieval for superseded and obsolete documents as well as completing requests for uploading documents into the ADMS QD Repository.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.
- 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.
- 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.