Specialist QC I

2 days ago

Singapore Amgen Inc. (IR) Full time

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
Specialist QC I
in Singapore.
Live
What you will do
Ensure laboratory systems and operations meet GMP compliance and Amgen Quality Management System requirements.
Work in a cross-functional team with Process Development, Manufacturing, Supply Chain, Engineering, and Facilities to ensure product quality and market supply.
Provide technical support to ensure that the manufactured products meet the applicable regulatory standards and guidelines with respect to Quality Control.
Coordinate work, tasks, and projects assigned to the teams.
Responsible for planning, scheduling, and performing laboratory testing and approval of test results on incoming raw materials, utility water, in-process control, drug substance intermediate, final release, stability, and plant cleaning samples in a GMP pharmaceutical environment.
Conduct or lead laboratory investigations and assist in timely closure of investigations, CAPAs, and deviations.
Support laboratory operations including but not limited to equipment qualification, calibration, cleaning and maintenance, and reagent/buffer preparation.
Lead/participate in new product introduction and support method verification/validation/transfer.
Facilitate training of new/junior laboratory staff and ensure all staff are appropriately trained and qualified to execute the duties assigned to them with respect to the job.
Author SOPs/protocols/reports.
Support periodic review of laboratory procedures, technical study protocols, reports, and assessments (e.g., trend reports, risk assessments).
Act as a subject matter expert for areas including but not limited to sample plans, lab electronic systems (such as LIMS), trending (such as method trending, assay control trending, EM & utilities), laboratory metrics, equipment system owners, and method owners.
Prepare, support audits, and represent the Quality Control function during regulatory inspections.
Lead continuous improvement initiatives and projects.
Any other tasks assigned by the supervisor/QC Manager.
All listed tasks and responsibilities are deemed essential functions of this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
Win
What we expect of you
Qualifications
Doctorate degree in Chemistry, Biochemistry, Life Science, or related technological field OR
Master’s degree in Chemistry, Biochemistry, Life Science, or related technological field and 2 years of directly related experience OR
Bachelor’s degree in Chemistry, Biochemistry, Life Science, or related technological field and 4 years of directly related experience.
High school diploma/GED in Chemistry, Biochemistry, or related technological field and 8 years of directly related experience.
6-8 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry and laboratory testing experience preferred.
Strong knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation, and associated testing methods.
Demonstrated knowledge and application of sound scientific principles, theories, techniques, and skills.
Demonstrated experience in GMP laboratory operation including development and management of systems for equipment qualification, method validation/transfer, sample management, data management, trending, and OOS investigations.
Strong technical knowledge in and experience with the following QC Chemistry/Biochemistry testing methods and equipment is required:
Immunosorbent Assay/Cell-based Bioassay: Potency, Host Cell Proteins, ELISA.
Chromatography: UPLC, HPLC, LC-MS, GC-HS.
General Chemistry: Capillary Electrophoresis, ICP-MS, LOD, Autotitration, KF, Optical Rotation, FT-IR, Conductivity, TOC, pH, wet chemistry.
Meticulous in assay review and approvals.
Ability to forecast workload, assess incoming sampling and testing volume, plan and coordinate assignment of shift work, and allocate/re-allocate resources accordingly.
Ability to work well with teammates of varying working styles and gel the team together.
Ability to preempt issues and disruptions to lab operations and develop mitigation actions.
Problem-solving skills with the ability to apply logic, utilize technical knowledge, and assess data to troubleshoot issues and derive appropriate GMP decisions and solutions.
Ability to coach, mentor, and/or cross-train staff within core technical areas.
Ability to assess individuals' strengths and weaknesses.
Good communication skills (technical writing and verbal communication/presentation).
Interact effectively with cross-functional teams and ability to work well in teams.
Ability to manage multiple simultaneous activities in a rapidly changing environment.
Leadership skills and keen on developing into management roles in the future.
Ability to make decisions in relation to laboratory operations in the absence of the manager.
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.
What you can expect of us
As we work to develop treatments that take care of others, we also 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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