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The purpose of this position within the Quality Assurance department is to support on-going development programs for preclinical, clinical, and commercial drug candidates at Arrowhead. A key function of the position will involve review of manufacturing batch records, analytical data and reports, and associated documents within the Quality Assurance department and will also support general quality systems related to current Good Manufacturing Practices (cGMP) within the organization. The Specialist II is expected to interact with multiple internal departments.
Job Responsibility:
Interact with representatives from other departments, including manufacturing, QC, and Analytical Development, to obtain the necessary information for review of documentation
Review and approve analytical testing data and final reports from internal and external sources with minimal supervision
Review and approve manufacturing batch records, forms, and associated testing with minimal supervision
Perform room releases as required
Perform QA on the floor as required
Assist with investigations and deviations as appropriate with minimal supervision
Organization and control of project related documentation
Issue, review, and reconcile controlled forms
Review, verify, and reconcile labels
Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval
Maintain knowledge of current compliance expectations and regulations pertaining to drug development
Assist with Good Documentation Practices, GMP, and data integrity training as needed
Additional duties as assigned
Requirements:
BS/BA in Chemistry, Biology, Biochemistry, or related scientific field is preferred
3 years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical manufacturing environment
Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents
Nice to have:
Experience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, and EU GMP, including Annex 11 and 15)
Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet
Prior experience with use of an electronic document management system in a regulated environment
What we offer:
competitive salaries and an excellent benefit package