About the Company
Bio-Rad Laboratories is a global leader in the development, manufacture, and marketing of a broad range of innovative products for the life science research and clinical diagnostic markets. With a commitment to quality and scientific advancement, we empower scientists and clinicians worldwide to achieve their goals. Joining Bio-Rad means contributing to breakthroughs that improve lives through cutting-edge technology and rigorous quality standards.
Job Description
As a Senior QC Analyst at Bio-Rad Laboratories, you will play a critical role in ensuring the quality and integrity of our life science products. You will be responsible for performing complex analytical testing, developing and validating new methods, and providing technical leadership within the Quality Control department. This position offers significant opportunities for impact and growth, supported by performance bonuses and relocation assistance for eligible candidates. You will work within a dynamic team, contributing to the release of high-quality products that meet stringent regulatory and internal standards.
Key Responsibilities
- Perform complex analytical testing of raw materials, in-process samples, and finished products using various analytical techniques (e.g., HPLC, GC, UV/Vis, FTIR, ELISA).
- Develop, optimize, and validate new analytical methods in accordance with ICH guidelines and cGMP principles.
- Review and interpret analytical data, troubleshoot issues, and provide technical guidance to junior analysts.
- Ensure all testing and documentation comply with cGMP, GLP, internal SOPs, and regulatory requirements.
- Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results, initiating and leading root cause analysis.
- Maintain, calibrate, and qualify laboratory equipment, ensuring proper functionality and data integrity.
- Lead or participate in quality investigations, audits, and continuous improvement initiatives.
- Prepare comprehensive technical reports, summaries, and presentations.
- Provide training and mentorship to new and junior QC personnel.
Required Skills
- Minimum of 5 years of experience in a Quality Control laboratory within the pharmaceutical, biotechnology, or medical device industry.
- Proficiency in advanced analytical techniques such as HPLC, GC, UV/Vis spectrophotometry, FTIR, and ELISA.
- Strong understanding and practical experience with cGMP, GLP, and ICH guidelines.
- Experience with method development and validation.
- Demonstrated ability to troubleshoot analytical instrumentation and methods.
- Excellent data analysis, critical thinking, and problem-solving skills.
- Proficient in using Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN).
- Strong written and verbal communication skills.
Preferred Qualifications
- Master's degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific field.
- Experience with mass spectrometry (LC-MS/MS, GC-MS).
- Familiarity with statistical software for data analysis (e.g., Minitab, JMP).
- Previous experience leading OOS/OOT investigations.
- Experience with regulatory submissions and audits.
Perks & Benefits
- Competitive salary with performance-based bonuses.
- Relocation assistance for eligible candidates.
- Comprehensive health, dental, and vision insurance.
- 401(k) retirement plan with company matching.
- Paid time off, including vacation, sick leave, and holidays.
- Life and disability insurance.
- Employee stock purchase program.
- Opportunities for professional development and career advancement.
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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