As a key member of the GMP Quality team, day-to-day activities of the Quality Assurance Manager will include review of Master and Executed Batch records, QA support for manufacturing and laboratory deviations/investigations, oversight of Vendor QC testing, data review/ approval, protocol, and report review/ approval, and final disposition of Akouos product. The Manager, QA will also provide QC review of Regulatory Submissions and external publications, including manuscripts and posters. In addition, the candidate will also contribute to QA department improvement projects.
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
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