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Job: Quality Assurance Specialist-Can work Remotely, Asklepios BioPharmaceuticals Inc, Durham, NC
Quality Assurance Specialist-Can work Remotely
Durham, NC 27709 United States
The Quality Specialist position will review/approve software validation (ZenQMS, DocuSign, WingSpan), maintenance of documents supporting the Quality Management System. They will be responsible for coordinating the creation, review/approval workflows of SOPs/Policies/Work Instructions/Forms/Methods, as well as the periodic review (every two years). Assist in the coordination of Corrective and Preventative Actions (CAPAs). Assist with the creation and maintenance of an approved vendor list and tracking of when qualifications are due. Track and generate quality metrics.
1) Perform the initial QA review and approval of software validation and any updates to meet timelines for initial release of the software and subsequent version releases.
3 software systems currently are included in the QMS (ZenQMS, WingSpan, DocuSign)
2) Coordination of the creation, review, approval, publishing and maintenance of SOPs/Policies/Work Instructions/Forms/Methods – priority procedures have been identified and target timelines for publishing would be established once person is on board.
3) Compilation and publishing of quality metrics for process improvement.
Metrics should be generated at least quarterly to allow for improvement opportunities to be identified (i.e., non-compliances, deviations, CAPAs, training compliance, timeline adherence)
4) Maintenance of information to achieve an approved vendor list and tracking of qualifications.
? The assessment of which vendors currently being used or planned to be used soon and which require a formal qualification is in progress.
-Bachelors degree in science preferred, but industry experience will also be considered
-5+ years experience working in a Quality Assurance role with validation, writing SOPs, tracking documentation and CAPAs within the biotech or pharma industry
-Demonstrated effective writing and verbal communication skills
-Ability to work independently once knowledge of assignments and goals are communicated
-Strong ability to accomplish goals and tasks within agreed upon timelines
-Demonstrated organizational skills for tracking of documentation
-Experience with Project Management skills
-Ability to travel to Homeoffice in Durham, NC every quarter
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North Carolina Biotechnology Center