About the Company
Johnson & Johnson is a global leader in healthcare innovation, dedicated to improving the health and well-being of people worldwide. With a legacy spanning over a century, we develop and produce a broad range of products in medical devices, pharmaceuticals, and consumer health. Our commitment to quality, research, and patient care drives everything we do. Join our team in Jacksonville and contribute to a healthier future.
Job Description
We are seeking a highly motivated and experienced Senior QC Analyst to join our Quality Control team in Jacksonville, Florida. In this critical role, you will be responsible for performing complex analytical testing on raw materials, in-process samples, and finished products to ensure they meet stringent quality standards and regulatory requirements. The successful candidate will play a key role in method development and validation, troubleshooting analytical issues, and providing guidance to junior analysts. This position offers an exciting opportunity to contribute to product quality within a world-class manufacturing environment, with the added benefits of performance bonuses and relocation assistance for eligible candidates.
Key Responsibilities
- Execute complex analytical tests (e.g., HPLC, GC, UV-Vis, FTIR, titrations) on various samples according to cGMP/GLP guidelines and SOPs.
- Review and interpret analytical data, ensuring accuracy, integrity, and compliance with specifications.
- Develop, optimize, and validate analytical methods in accordance with ICH guidelines and regulatory requirements.
- Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results, conducting root cause analysis and implementing corrective actions.
- Perform calibration, maintenance, and troubleshooting of laboratory instrumentation.
- Provide technical guidance and mentorship to junior QC analysts, fostering a culture of continuous improvement.
- Author and revise standard operating procedures, test methods, and technical reports.
- Participate in internal and external audits, ensuring laboratory readiness and compliance.
- Maintain accurate and detailed laboratory records and documentation.
- Contribute to continuous improvement initiatives within the QC department.
Required Skills
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
- Minimum of 6 years of experience in a Quality Control laboratory within a cGMP regulated environment (pharmaceutical, medical device, or biotechnology).
- Expertise in operating and troubleshooting analytical instrumentation (HPLC, GC, UV-Vis, FTIR).
- Strong understanding of cGMP, GLP, ICH guidelines, and regulatory requirements (FDA, EMEA).
- Proficiency in method development, validation, and transfer.
- Demonstrated ability to investigate and resolve OOS/OOT results.
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
Preferred Qualifications
- Master's degree in a relevant scientific discipline.
- Experience with LIMS and electronic data management systems.
- Knowledge of statistical analysis tools for data interpretation.
- Previous experience leading small projects or mentoring junior staff.
- Familiarity with Lean Six Sigma principles.
Perks & Benefits
- Competitive salary with performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Generous paid time off and holidays.
- Relocation assistance package for eligible candidates.
- Tuition reimbursement and professional development opportunities.
- Employee assistance programs.
- On-site fitness centers or wellness programs.
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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