Quality Assurance Documentation Specialist
5 days ago
At PSG Global Solutions Careers, we're seeking a highly skilled Quality Assurance Documentation IV to join our team in the Pharmaceuticals and Medical Products industry. This exciting opportunity is based in 100 College Street, New Haven, Connecticut, United States.
Job SummaryWe're looking for a detail-oriented and organized individual to perform activities for the ongoing development and operations of the Country Quality QMS optimization project. This includes carrying out operational requirements resulting from policies, procedures, regulations, and guidances governing the management of records in print and electronic form.
Key Responsibilities- Manage the electronic documentation of records, liaise with internal/external Document Management and Country Quality support staff, and oversee QMS Optimization project plan activities.
- Develop, implement, and evaluate records management processes and systems, including cataloging, filing, and retrieving of records.
- Ensure compliance with GMP global regulatory requirements and experience with electronic systems (e.g. FirstDoc and TrackWise) and databases.
- BS/BA degree in a STEM-related field of study or equivalent experience.
- Minimum of 7 years GMP-related experience in biopharmaceutical/pharmaceutical or related industry.
- Experience with electronic systems, databases, and records management processes.
Our client is an award-winning clinical development company with 20+ years of experience in clinical research and strategic resourcing. They improve lives globally with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations, they provide strong relationships, connections, and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training.
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