Remotely
auditquality assuranceqacmcregulatorygmpanalyticallaboratory
Job Description
📋 Description
- Hybrid role based in AbbVie locations: North Chicago, IL; Cambridge, MA; Irvine, CA; San Francisco
- Lead Product Development QA from an analytical perspective in support of clinical supply release.
- Support CMC teams in resolving complex analytical challenges through development phases.
- Provide leadership and daily support to the Lab QA team.
- Drive continuous process improvement within Product Development QA by updating/authoring policies
- Lead QA Analytical audit/inspection preparation and support audits/inspections as QA SME.
🎯 Requirements
- Bachelor's degree or equivalent in life sciences or engineering; Master’s preferred but not
- 6-8 years of experience in QA and/or analytical sciences, or related field.
- Strong understanding of API and drug product GMP manufacturing as applied to laboratory operations
- Strong understanding of US and international quality system regulations and compliance for
- Experience in project management, coordination, and planning of complex activities.
- Collaborative, risk-based problem solving approach; strong oral and written communication to convey
🎁 Benefits
- AbbVie offers a comprehensive package of benefits including PTO, medical/dental/vision insurance
- This job is eligible to participate in long-term incentive programs.
- Equal opportunity employer; information on accommodations and EEO can be found on AbbVie’s site.