About the Company
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing laboratory productivity, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands.
Job Description
We are seeking a highly skilled and motivated Senior QC Analyst to join our quality control team in New Port Richey, FL. This pivotal role involves conducting complex analytical testing on raw materials, in-process samples, and finished products to ensure they meet stringent quality standards and regulatory requirements. The Senior QC Analyst will play a critical role in maintaining the highest levels of product quality, supporting investigations, and contributing to continuous improvement initiatives. If you are passionate about quality, possess strong analytical skills, and thrive in a dynamic, regulated environment, we encourage you to apply.
Key Responsibilities
- Perform advanced analytical testing on raw materials, in-process, and finished products using various techniques (e.g., HPLC, GC, FTIR, UV-Vis, KF, dissolution) in a GMP/GLP compliant laboratory.
- Interpret and analyze complex data, troubleshoot analytical methods, and identify out-of-specification (OOS) results, initiating and participating in investigations.
- Develop, validate, and transfer new analytical methods as needed, ensuring robustness and compliance with regulatory guidelines.
- Maintain, calibrate, and troubleshoot laboratory instrumentation, ensuring all equipment is in optimal working condition and adheres to preventative maintenance schedules.
- Prepare comprehensive documentation, including test reports, method validation protocols, and OOS investigation reports, ensuring accuracy and completeness.
- Mentor and train junior QC analysts on analytical techniques, laboratory procedures, and regulatory compliance.
- Collaborate with R&D, Manufacturing, and Regulatory Affairs teams to support product development, manufacturing processes, and regulatory submissions.
- Participate in internal and external audits, providing expert support and responding to audit observations.
- Drive continuous improvement initiatives within the QC department to enhance efficiency, quality, and compliance.
Required Skills
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
- Minimum of 5 years of experience in a Quality Control laboratory within a pharmaceutical, biotechnology, or medical device manufacturing environment.
- Extensive hands-on experience with analytical techniques such as HPLC, GC, FTIR, UV-Vis, and Karl Fischer titration.
- Thorough understanding of GMP, GLP, and relevant regulatory guidelines (e.g., FDA, ICH).
- Proficiency in data analysis, statistical methods, and laboratory information management systems (LIMS).
- Strong problem-solving and troubleshooting skills, particularly in method development and OOS investigations.
- Excellent written and verbal communication skills, with the ability to present complex technical information clearly.
- Ability to work independently and collaboratively in a fast-paced, team-oriented environment.
Preferred Qualifications
- Master's degree in a relevant scientific discipline.
- Experience with method validation and transfer activities.
- Familiarity with Empower, Chromeleon, or similar chromatography data systems.
- Experience in a leadership or mentoring role within a QC laboratory.
Perks & Benefits
- Competitive salary with performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans.
- 401(k) retirement plan with company match.
- Paid time off, including vacation, sick leave, and holidays.
- Life and disability insurance.
- Employee assistance program.
- Tuition reimbursement and professional development opportunities.
- Relocation assistance for eligible candidates.
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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