About the Company
Amgen is one of the world’s leading biotechnology companies, committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. Our team is driven by a shared mission to serve patients and a deep commitment to science and innovation. We foster an environment where talent thrives, and contributions are recognized and rewarded.
Job Description
We are seeking a highly motivated and experienced Senior QC Analyst to join our Quality Control team in Long Beach, CA. In this critical role, you will be responsible for performing complex analytical testing on raw materials, in-process samples, and finished products to ensure compliance with cGMP regulations and established specifications. Your expertise will be vital in supporting our product development and manufacturing processes, ensuring the highest quality standards are consistently met. This position offers significant opportunities for growth, performance-based bonuses, and relocation assistance for qualified candidates.
Key Responsibilities
- Perform advanced analytical testing using a variety of techniques (HPLC, GC, spectroscopy, wet chemistry, etc.) on pharmaceutical raw materials, in-process materials, and finished products.
- Review and interpret complex analytical data, identifying trends and deviations.
- Troubleshoot analytical instrumentation and methods, ensuring optimal performance and accuracy.
- Develop, validate, and transfer analytical methods as needed, adhering to regulatory guidelines.
- Author and review technical documents, including test methods, specifications, validation protocols, and reports.
- Ensure all testing activities comply with cGMP, ICH, and corporate quality standards.
- Train and mentor junior QC analysts on techniques, procedures, and quality systems.
- Participate in OOS (Out-of-Specification) investigations, root cause analysis, and CAPA implementation.
- Contribute to continuous improvement initiatives within the QC laboratory.
Required Skills
- Minimum 5 years of experience in a GMP-regulated Quality Control laboratory, preferably within the biotechnology or pharmaceutical industry.
- Proficient in advanced analytical techniques such as HPLC, GC, UV/Vis spectroscopy, FTIR, and dissolution testing.
- Strong understanding of cGMP, ICH guidelines, and pharmaceutical quality systems.
- Excellent data analysis, interpretation, and problem-solving skills.
- Ability to troubleshoot analytical instruments and methods effectively.
- Demonstrated ability to write clear and concise technical documentation (SOPs, reports, protocols).
- Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline.
Preferred Qualifications
- Master's degree in a relevant scientific field.
- Experience with LIMS (Laboratory Information Management System) and other electronic quality systems.
- Knowledge of method development and validation principles.
- Experience with statistical process control (SPC) and data trending.
- Prior experience mentoring or leading junior team members.
Perks & Benefits
- Competitive base salary with annual performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans.
- Generous paid time off and holidays.
- 401(k) retirement plan with company matching.
- Relocation assistance package for eligible candidates.
- Tuition reimbursement and professional development opportunities.
- Employee assistance program and wellness initiatives.
- On-site fitness centers or subsidized gym memberships.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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