Job Details
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The Opportunity
Description
We're looking for a Quality Assurance Documentation IV, working in Pharmaceuticals and Medical Products industry in 100 College Street, New Haven, Connecticut, United States.
Job description:
- Perform activities for the ongoing development and operations of the Country Quality QMS optimization project.
- Carry out the operational requirements that result from policies, procedures, regulations, and guidances governing the management of records that exist in print and electronic form.
- Help manage the electronic documentation of records, liaise with other internal/external Document Management and Country Quality support staff, and the management of QMS Optimization project plan activities.
Our ClientOur client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your SuccessRequirements:
- BS/BA degree in STEM related field of study preferred; will consider a commensurate level of education and experience
- Minimum of 7 years GMP related experience in biopharmaceutical/pharmaceutical or related industry
- Experience with electronic systems (e.g. FirstDoc and TrackWise) and databases
- Capable of moving, copying and recovering large numbers of files and folders in a Windows environment
- Experience in developing, implementing, and evaluating records management processes and systems. This includes cataloging, filing, and retrieving of records
- Experience with GMP global regulatory requirements
What Do You Think?Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?