Senior Associate Quality Control

Amgen•Holly Springs, NC

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Associate Quality Control What you will do Let’s do this. Let’s change the world. In this vital role you will play a key role in the Quality Control team as the site’s Business Process Owner (BPO) for laboratory notebook and consumable management computerized systems. Reporting directly to the Manager of Quality Control Support, you will serve as a subject matter expert for QC on the implementation, usage, and governance of laboratory-based computerized systems used for documentation of analytical testing and consumables management. You will lead and direct other QC and cross-functional staff as an informed Subject Matter Expert (SME). The SME will apply sophisticated thinking to ensure quality and compliance with GMP regulations for QC digital operations. Because this role is tightly integrated with manufacturing operations, occasional extended hours, shift work, or weekend support for troubleshooting may be required. Working under minimal supervision, the successful candidate will contribute to both startup and daily operations of the QC organization by:

Requirements

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
Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners is critical

Nice To Haves

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.

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.