Specialist Qc I

7 days ago

Singapore Amgen Full time

**R-203502 Specialist QC I**

**Singapore**

**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 **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
- Provides technical support to ensure the manufactured products meet the applicable regulatory standards and guideline with respect to Quality Control.
- Coordinate work, tasks and project assigned to the teams.
- Responsible for planning, scheduling and performing laboratory testing and approval of test results on in-coming 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, reagent/buffer preparation.
- Lead/ participate in new product introduction and support method verification/ validation/ transfer.
- Facilitate training of new/ junior laboratory staff and sure all staff are appropriately trainined and qualified to execute the duties assigned to them with respect to the job.
- Author of SOP/protocols/reports.
- Support periodic review of laboratory procedures, technical study protocols, reports and assessments (e.g trend reports, risk assessments)
- Subject matter expert for areas including but not limited to sample plans, lab electronic systems (such as LIMS, LIMS templating), trending (such as method trending, assay control trending, EM & utilities), laboratory metrics, equipment system owners and method owners.
- Prepare, support audit and represent 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 as essential functions to 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 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
- Ability to coach, mentor and/or cross train staff within core technical areas
- Ability to assess individual’s strength and weaknesses
- Good communication skills (technical writing and verbal communication/presentation)
- Interact effectively with cross functional team and ability

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