Job Title: Quality Management Specialist
Location: Remote
Job Summary: We are seeking a specialist to support batch record review and quality management activities within a leading pharmaceutical organization. Our team is focused on ensuring the integrity and compliance of biological products throughout commercial distribution and clinical development phases.
Responsibilities:
- Manage batch record review to support product release and GPQ activities for commercial and clinical products.
- Update trackers, identify trends in record reviews, and collaborate with cross-functional stakeholders and external partners to facilitate product release.
- Oversee preparation and review of specifications, bills of materials, master batch records, and documentation related to process changes, investigations, and root cause analyses.
- Utilize digital quality management systems for documenting quality events, change controls, batch records, and reviewing analytical reports such as stability and retention reports.
Required:
- Experience in biological product manufacturing, specifically monoclonal antibody products.
- Minimum of five years’ combined experience in pharmaceutical manufacturing, QA, or QC assurance supporting commercial products and development projects; 5-7 years preferred in batch review and release with suppliers or contract manufacturers.
- Bachelor’s degree in Chemistry, Biology, or other Physical Sciences.
- Demonstrated knowledge of GMP requirements for batch review and release, familiarity with FDA 21 CFR 211 and 210, and experience using TrackWise or similar Quality Management Systems for handling deviations and quality events.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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