Career Category

Job Description

Job Summary

Under minimal supervision, the Manager Quality Control will be responsible for overseeing day to day activities in microbiology (including but not limited to routine environmental & utilities monitoring; raw material and product testing such as bioburden, microbial limits test, endotoxin, qPCR, microbial ID; media, reagent and culture qualification such as growth promotion; etc.), sample management and stability (including but not limited to sample logging, receipt and processing, sample aliquoting, movement and storage of samples, stability initiations and time point pulls, etc.).  The Manager Quality Control will collaborate with the global Amgen QC network and provide on-site support and collaboration for both biologics and small molecule manufacturing.

• Responsible for leading and supervision of staff, maintenance of the team’s weekly schedule and prioritization of daily work tasks
• Responsible for providing Quality oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP) and other applicable regulations
• Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
• Performs review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to nonconformance records, change control and Corrective Actions / Preventative Actions (CAPAs)
• Supports Continual Improvement and LEAN initiatives, programs and projects
• Ensures that changes that could potentially impact product quality are assessed according to procedures
• Ensures that deviations from established procedures are investigated and documented per procedures
• Ensures that records are complete, accurate, and documented according to written procedures and cGMP requirements
• Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
• Alerts senior management of quality, compliance, supply and safety risks
• Represents the quality unit during audits and inspections
• Supports internal/external audits and inspections as part of the audit/inspection management team

Basic Qualifications

Doctorate degree
OR
Master’s degree and 3 years of Quality or Operations experience
OR
Bachelor’s degree and 5 years of Quality or Operations experience
OR
Associate’s degree and 10 years of Quality or Operations experience
OR
High school diploma / GED and 12 years of Quality or Operations experience
AND
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications

• Strong knowledge and understanding of microbiology testing methodology and strategy for contamination control
• Knowledge and experience with general GMP laboratory operations, data integrity requirements and associated laboratory equipment
• Experience with computerized laboratory information management systems, electronic laboratory notebooks and other QC analytical equipment
• Ability to lead diverse teams
• Good communication skills (technical writing and verbal communication/presentation)
• Ability to work in cross-functional and multisite teams
• Interact effectively with variety of communication and working styles
• Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.