Senior Associate Quality Assurance Specialist
2 days ago
We are seeking a highly skilled Quality Assurance professional to join our team at Amgen's North Carolina site. As a Senior Associate Quality Assurance, you will play a critical role in ensuring the quality of raw materials received at our site, supporting the inspection, sampling, and testing of these materials.
Key Responsibilities- Inspect materials, including biobags, tubing, filters, and other components, to ensure compliance with specification requirements and master inspection characteristics.
- Perform sampling from containers of media and other chemicals to facilitate testing.
- Use Raman technology with TruScan equipment to identify chemicals and ensure accurate results.
- Responsible for accurately detailing inspection, sample, and test results in Amgen's systems.
- Lead/participate in inspections/walkthroughs to ensure facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP regulations and other safety standards.
- Oversee the warehouse's quality assurance, managing quality documentation, ensuring compliance with procedural standards, and verifying evaluations and assessments of various partners.
- Support inspection readiness activities, including site audits and inspections.
- Maintain project plan commitments, supporting critical projects.
- Lead and support Continual Improvement initiatives, programs, and projects.
- Serve as a shift lead in the raw material inspection and sampling areas.
- Assist area management with prioritization and scheduling of tasks.
- Serve as a trainer and subject matter expert in tasks associated with raw material inspections, samples, and testing.
- Author, own, review, and approve controlled documents for the area, including SOPs and FORMs.
- Initiate and own deviation records and CAPAs associated with events and projects in ANC's raw material inspections, samples, and testing areas.
- High school diploma/GED and 4 years of cGMP inspecting and/or sampling experience, or equivalent combination of education and experience.
- Strong understanding of cGMP regulations and GDP requirements.
- SAP, LIMs, and TrackWise experience.
- Experience with Raman technology.
- Experience as a trainer in raw material inspections, sampling, and testing.
- Ability to lift and perform physical activities with raw materials.
- Strong written and verbal communication skills.
At Amgen, our shared mission to serve patients drives all that we do. We are a leading biotechnology company, reaching over 10 million patients worldwide. Our newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility, combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. We are committed to being a carbon-neutral company by 2027 and are dedicated to making a positive impact on the environment and our communities.
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