Summary:
The QA Associate will be responsible for supporting and fostering quality assurance (QA) requirements and activities related to cGXP (primarily GMP but also including Good Laboratory Practice and Good Distribution Practice) in accordance with ICH and FDA regulations and guidelines. This position will also be responsible for quality and regulatory compliance and help assure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines. The primary function of the department is to build, monitor and sustain a robust and effective quality system that delivers reliable, high – quality products that meet all customer and regulatory agency requirements and expectations.
Duties and Responsibilities:
- Compile Lot Documentation pdfs (including bookmarking combined pdfs)
- Upload Manufacturing and Quality Documents into Veeva eDMS System
- Support backlog (“bulk”) of manufacturing documents in the Veeva Quality Management System (QMS)
- Perform data entry and document uploading into Veeva
- Rename and organize documents using established naming conventions
- Upload finalized documents into the Veeva system and ensure proper filing
- Ensure documents meet quality and compliance standards
- Work independently and efficiently to complete tasks
- Supporting day to day activities as necessary
- Perform other duties as assigned
- Upload manufacturing documents into Veeva – Initial Backlog Reduction:
- Wakix
- Zynerba
- EPX-100
- NG1
- Including documents related to raw materials, Key intermediates, API, Drug Product, Packaging, Labeling, validation protocols and reports, technical reports, etc.
- Upload manufacturing documents into Veeva – Maintenance
- Assist with Veeva reports for Wakix Annual Product Quality Review
- Other: supporting day to day activities as necessary
- Training time to get up to speed on the tasks
Qualifications:
- Bachelor of Science in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology preferred
- 3+ years’ experience in pharmaceutical operations preferred
- Previous exposure to functional areas of quality assurance
- Experience working with electronic quality systems such as Veeva is strongly preferred
- High ethical & quality standards and lives them through actions and communication
- Demonstrated ability to function independently with minimal guidance
- Strong computer (especially Adobe), organizational, and attention-to-detail skills required
- Strong verbal and written communication skills
- Must think critically and creatively, and have strong organizational and planning skills
PA: QA Doc Consultant (237050)
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