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Senior Associate, QA ComplianceScorpion TherapeuticsSan Diego, California, United States
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Senior Associate, QA Compliance

Scorpion Therapeutics
  • US
    San Diego, California, United States
  • US
    San Diego, California, United States

Über

This position is responsible for Quality Assurance Compliance activities supporting deviations, CAPAs, change control, and product releases. Responsibilities Support deviation and CAPA/SCAR systems by investigating, reviewing, assessing, tracking, follow-up, and completing quality events. Support the Change Control program by reviewing, assessing, tracking, follow-up, and completing documentation. Maintain databases and metrics. Identify and communicate compliance gaps; propose phase-appropriate solutions. Track the status of deviations, CAPAs, and change controls. Perform internal and/or external audits, as needed. Support product releases by reviewing batch records. Support risk assessment activities. Support audits by regulatory or state agencies and partners. Follow applicable regulations (including FDA, ISO, ICH) and company policies/procedures. Support other QA department needs as identified by management. Qualifications / Requirements Bachelor’s degree or a combination of relevant education and applicable job experience. 5+ years’ experience in an FDA-regulated industry and CGMP regulations. Late-phase to commercial phase experience (plus). Cell therapy experience (plus). Benefits Medical, Dental, Vision; Group Life Insurance; Long Term Disability (LTD); 401(k); EAP; FSA; Paid Time Off (PTO); company paid holidays (including year-end holiday week).
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  • San Diego, California, United States

Sprachkenntnisse

  • English
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