Amgen · 2 hours ago
Quality Assurance Specialist
US - North Carolina - Holly Springs
Full-time
Onsite
Mid, Senior Level
$113K/yr - $132K/yr
4+ years expAmgen is a biotechnology company dedicated to serving patients with serious illnesses. In this role, the Quality Assurance Specialist will provide oversight and guidance to ensure compliance with manufacturing and quality standards while collaborating closely with various departments to uphold quality systems.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Responsible for providing Quality oversight to ensure that Operations’ products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA)
Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports
Oversee and provide guidance during on-the-floor analytical testing
Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
Ensure that changes that could potentially impact product quality are assessed according to procedures
Ensure that deviations from established procedures are investigated and documented per procedures
Alert senior management of quality, compliance, supply and safety risks
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation
Identification and implementation of continuous improvement opportunities within our processes and systems
Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections
Qualification
Required
High school diploma / GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Associate's degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Bachelor's degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Master's degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Doctorate degree
Preferred
Educational background in Life Science or Engineering
Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations
Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition
Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian)
Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
Experience participating in, managing, and responding to health authority inspections, partner and corporate audits
Strong organizational skills, including ability to follow assignments through to completion
Excellent written and verbal communication skills
Benefits
Competitive and comprehensive Total Rewards Plans
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
2026-01-22
2026-01-20
Company data provided by crunchbase