Senior Associate Quality Control

Role Summary

Senior Associate Quality Control at Amgen, serving as the site’s Business Process Owner for laboratory notebook and consumables management computerized systems within the Quality Control organization. You will act 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 guide QC and cross-functional staff as an SME to ensure quality and GMP compliance for digital QC operations, with occasional extended hours or weekend support as operations require.

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 understanding of laboratory processes and procedures.
• Lead efforts to capture data and requirements from analytical testing groups to interface with corporate teams for 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 interact with regulatory agencies during inspections.
• Provide project management support, leading efforts to drive timely task completion and develop strategies for equipment implementation; support Lean Transformation and Operational Excellence initiatives.
• Ensure that all activities and related documentation comply with GMP, Good Documentation Practices, Safety, and Controls per applicable regulations and Amgen requirements.

Qualifications

• 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 experience OR Bachelor’s degree and 6 months of experience OR Master’s degree.
• Preferred: Excellent written and verbal communication skills; ability to work in a matrix environment and build relationships with partners.
• Preferred: Experience using Biovia systems including LES, ELN, and CIMS/CISPro.
• Preferred: Analytical testing background in Chemistry, Bioassay, or Microbiology.
• Preferred: System validation knowledge and experience interfacing with IT and QA teams throughout the system lifecycle.
• Preferred: Strong understanding of Data Integrity, Good Documentation Practices, and 21 CFR 11 compliance in a GMP environment.
• Preferred: Familiarity with USP-NF.
• Preferred: Experience executing test scripts in digital testing systems such as ALM.
• Preferred: Integration of analytical instrumentation in digital laboratory systems.
• Preferred: Strong organizational skills to support a wide range of projects in a fast-paced, evolving environment.
• Preferred: Great attention to detail and high accuracy in GMP documentation.
• Preferred: Ability to work autonomously, problem solve, and provide updates to senior management; identify potential issues.
• Preferred: Experience using Veeva Vault systems including QualityDocs (CDOCS) and QMS.

Skills

• Strong written and verbal communication; ability to work in a matrix environment and build relationships with partners.
• Knowledge of laboratory systems (LES, ELN, CIMS/CISPro) and GMP documentation practices.
• Data Integrity, Good Documentation Practices, and 21 CFR 11 compliance in a GMP environment.
• Project management and cross-functional collaboration.
• Integration of analytical instrumentation in digital laboratory systems.

Education

• High School Diploma or GED
• Associate’s degree
• Bachelor’s degree
• Master’s degree

Additional Requirements

• Occasional extended hours, shift work, or weekend support for troubleshooting may be required.