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Manager Quality Control (Micro and Sample Management) at Amgen Singapore Manufacturing. In this vital role, you will be responsible for QC Microbiology Shift teams. Responsibilities include leading and supervision of staff, maintenance of the weekly lab schedule and prioritization of daily work tasks. Providing Quality oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP). The Manager will ensure that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations. Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to nonconformance records and CAPAs.
Job Responsibility
Lead and supervise QC Microbiology Shift teams
Maintain the weekly lab schedule and prioritize daily work tasks
Provide Quality oversight to ensure processes follow cGMP
Ensure facilities, equipment, materials, organization, processes, procedures and products align with cGMP
Perform review, approval and tracking of cGMP processes, procedures, documents and records including nonconformance records and CAPAs
Oversee day to day activities in microbiology (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.)
Oversee sample management and stability (sample logging, receipt and processing, sample aliquoting, movement and storage of samples, stability initiations and time point pulls, etc.)
Collaborate with the global Amgen QC network
Provide on-site support and collaboration for both biologics and small molecule manufacturing
Present the QC Microbiology lab area during audits and inspections
Act as Functional Area Owner for microbiology testing, stability processing and shipment deviations
Oversee Microbiology laboratory investigations
Lead laboratory troubleshooting and problem-solving exercises
Manage Contract Test Lab sample lifecycle (purchase orders to results)
Oversee LIMS Lot Authorization and on-time lot disposition deliverables
Ensure compliance with safety guidelines, cGMPs and other applicable regulatory requirements
Support staff training, career development and performance management
Support site and global initiatives
Support implementation of new equipment and technologies
Support Continual Improvement and LEAN initiatives, programs and projects
Ensure changes that could potentially impact product quality are assessed according to procedures
Ensure deviations from established procedures are investigated and documented per procedures
Ensure records are complete, accurate, and documented according to written procedures and cGMP requirements
Collaborate cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
Alert senior management of quality, compliance, supply and safety risks
Represent the quality unit during audits and inspections
Support internal/external audits and inspections as part of the audit/inspection management team
Requirements
Doctorate degree
OR Master's degree and 2 years of Quality or Operations related experience
OR Bachelor's degree and 4 years of Quality or Operations related experience
OR Diploma and 8 years of directly related experience
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
What we offer
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits