QC Manager (Micro and Sample Management)

Career CategoryQuality

Job Description

Quality Control Manager (Micro and Sample Management)

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Quality Control Manager in Amgen Singapore Manufacturing.

Quality Control Manager (Micro and Sample Management)

Live

What you will do

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.

Main Responsibilities:

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

Win

What we expect of you

Qualifications

Doctorate degree OR

Master’s degree and 2 years of Quality or Operations experience OR

Bachelor’s degree and 4 years of Quality or Operations experience OR

Diploma and 8 years of directly related experience AND

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

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.

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

Vast opportunities to learn and move up and across our global organization

Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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