Amgen · 5 hours ago
Senior Associate Quality Control
Holly Springs, NC
Full-time
Onsite
Mid, Senior Level
2+ years expAmgen is a leading biotechnology company focused on serving patients with serious illnesses. The Senior Associate Quality Control will play a key role in the Quality Control team, serving as a subject matter expert for laboratory computerized systems and ensuring compliance with GMP regulations.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Provide support and guidance to laboratory users of Laboratory Notebook and Consumables Management computerized systems throughout the system lifecycle
Collaborate closely with QC teams to develop a strong solid understanding of laboratory processes and procedures
Lead effort to capture data and requirements from analytical testing groups to interface with corporate teams in support of the development, qualification, and implementation of QC master data
Author, review, and revise system related controlled documentation including SOPs, Work Instructions, trend reports, training materials, and validation documentation
Train laboratory users on system usage ensuring training records are compliant prior to requesting system access
Support deviation and CAPA records to maintain system compliance and quality standards
Contribute to the inspection readiness program and represent QC systems during regulatory audits; may directly interact with regulatory agencies during inspections
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for equipment implementation. Support Lean Transformation and Operational Excellence initiatives
Ensures that all activities and related documentation comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Qualification
Required
High school diploma / GED and 4 years of Quality, Analytical Testing, or GxP Computerized System validation experience OR
Associate's degree and 2 years of Quality, Analytical Testing, or GxP Computerized System validation experience OR
Bachelor's degree and 6 months of Quality, Analytical Testing, or GxP Computerized System validation experience OR
Master's degree
Preferred
Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners is critical
Experience using Biovia systems including Laboratory Execution System (LES), Electronic Laboratory Notebook (ELN), and Consumables Management (CIMS/CISPro)
Analytical testing background in one of the following areas: Chemistry, Bioassay, Microbiology
System validation knowledge and experience interfacing with Information Technology (IT) and Quality Assurance (QA) teams throughout the system lifecycle
Strong understanding of Data Integrity, Good Documentation Practices, and 21CFR11 compliance in a GMP environment
Familiarity with compendial methods such as USP-NF
Experience executing test scripts in digital testing systems such as ALM
Integration of analytical instrumentation in digital laboratory systems
Strong organizational skills to support a wide range of projects, issues, and results in a high-paced evolving environment
Great attention to detail and high degree of accuracy in task completion and GMP documentation
Ability to complete tasks autonomously, problem solve and provide updates to senior management and identify potential issues
Experience using Veeva Vault systems including: QualityDocs (CDOCS), QMS
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
2026-01-24
2026-01-22
Company data provided by crunchbase