Quality Engineer (Compliance/Validation)
Sterling Life Sciences - Raleigh, NC

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Partial Job Description
1) Ensure the site inspection readiness program is functioning and continuously improving
2) Follow-up and respond to 3rd party audit findings (i.e. FDA, ISO, customer, etc.)
3) Manage the Aging Records (CAPA, Complaints, Deviations, NCMR, Nonconformities) meeting with site and executive management ensuring key investigations are being completed on time and are adequate
4) Perform trending of quality systems to identify adverse trends and need for CAPA
5) Manage the backroom activities during FDA (government) inspections
6) Facilitate/host customer audits
7) Host 3rd party audits (FDA, ISO, Customer, etc.)
8) Coordinate collection of metrics/materials for semi-annual Quality System Management Review Meeting (QSMR)
9) Participate and lead project and investigation teams using quality tools such as Fishbone, 5 Why?s, Is/Is Not, etc.

Qualifications / Skills Required
1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the biotechnology industry is strongly preferred
4) Preference will be given to people who have recent experience in Quality

CareerBuilder - 2 years ago - save job