·         Management of various product line CAPA programs. Facilitate CAPA closure across the organization and assist with completing corrective actions required

·         Perform Internal Audits, including scheduling, conducting and reporting audit findings, CAPA generation and management

·         Assist with maintenance of the Supplier Management Program for product lines and assist with conducting audits at vendor sites, when needed

·         Review batch records including monthly RO/DI and weekly Environmental Monitoring, when required

·         Perform QA review and approval of document change requests (DCRs) for revisions to production documents, engineering drawings and pertinent SOPs

·         Facilitate the writing and closure of failure investigations and deviation reports associated with batch record review

·         Perform raw material release for both Quality Control and Manufacturing materials, including raw material specification updates

·         Responsible for mentoring and overseeing at least one direct report employee

·         QA review of production and QC documentation, and support activities, such as raw material release and maintaining files

·         Bachelor’s degree in Engineering strongly preferred. Biology, Chemistry, or equivalent will be considered

·         Minimum of 2-3 years’ experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent

·         Must have attention to detail and strong organizational skills

·         Must have experience with report writing, SOP revision and following up on corrective actions with demonstrated success

·         Supervisory experience is a plus

·         Previous auditing experience is a plus

·         Some travel may be required