Join a global biotechnology company as a QC Specialist in Singapore!
Are you passionate about quality control and quality management system? Do you want to be part of a leading company in the biopharmaceutical industry, known for its cutting-edge manufacturing capability and innovative human therapeutics? If so, we have the perfect opportunity for you!
Position: QC Specialist
Location: Singapore
About our Client:
Our client is a global multinational company at the forefront of the biopharmaceutical industry. Their commitment to innovation and excellence has made them a leader in biotechnology breakthroughs and human therapeutics.
Key Responsibilities:
- 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.
- 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.
What We're Looking For:
- Doctorate degree in Chemistry, Biochemistry, Life Science, or related technological field.
- Master's degree in Chemistry, Biochemistry, Life Science or related technological field and 2 years of directly related experience.
- 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 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.
Why Join Us?
- Innovative Environment: Work with cutting-edge technology and innovative products.
- Professional Growth: Opportunities for continuous learning and career advancement.
- Impactful Work: Contribute to products that improve patient outcomes and healthcare quality.
- Dynamic Team: Collaborate with a team of dedicated professionals who are passionate about what they do.
If you're ready to take your career to the next level and make a significant impact in the medical device industry, we want to hear from you!