Senior Validation Scientist QA/RA

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Join to apply for the Senior Validation Scientist QA/RA role at Meridian Bioscience Inc.

About Meridian

Meridian Life Science / Bioline develops, manufactures, and markets a wide range of specialized bio-research reagents that simplify, accelerate, and improve life sciences research.

Job Summary

The successful candidate will work as part of the QA/RA team with full responsibility for the MLS Molecular validation program, including validation of processes, analytical assays for new Meridian products, improving existing methods, developing new assays for legacy products, validating equipment and software, examination/assessment of product stability, troubleshooting, and undertaking projects in conjunction with other departments, primarily R&D, production, and operations. The role is laboratory-based with significant paperwork, and may involve supporting the QC department during busy times.

Key Duties

1. Responsibility for the Meridian Life Science Validation program at both UK and Germany sites.
2. Validation of analytical assays for new and legacy products.
3. Support of QC transfer, development, and re-development of QC assays.
4. Preparation, performing experimental assays for initial transfer testing, formal validations, and documentation of results.
5. Validation and risk assessments of production processes.
6. Validation, verification, and revalidations of equipment.
7. Validation of software.
8. Validation of non-verifiable processes and supporting process validation efforts.
9. Maintaining validation master plans.
10. Ensuring validation processes comply with ISO 13485.
11. Executing and maintaining internal equipment calibration and verification programs.
12. Managing long-term stability programs of Meridian products.
13. Analyzing, reviewing, optimizing, and developing analytical assays, including documentation, establishing procedures, and training.
14. Supporting the quality control team, including during high workload periods, performing special testing and troubleshooting.
15. Applying a risk-based approach per ISO 13485 standards.
16. Preparing documents related to assay development and validation in a timely manner.
17. Investigating and completing Non-Conformance reports and CAPA improvements.
18. Supporting continual improvement processes.
19. Managing a team of scientists.
20. Possessing advanced knowledge in validation standards and guidelines for assays, processes, equipment, and software.
21. Having hands-on experience with qPCR, isothermal amplification assays, end point PCR, enzymology, biochemical assays, and molecular biology techniques.
22. Knowledge of analytical methods including spectroscopy, chromatography, electrophoresis, and practical experience with them.
23. Good regulatory knowledge of ISO 13485 and related validation documentation requirements.
24. Understanding risk-based approaches within ISO 13485.

Qualifications

1. MSc, PhD, or equivalent in life sciences.
2. 5-7 years of relevant industry experience preferred.
3. Ability to develop, optimize, and validate analytical assays using qPCR, PCR, spectrophotometry, chromatography, and molecular biology techniques.
4. Advanced troubleshooting skills for problematic assays.
5. Proficiency in statistical analysis.
6. Strong technical writing skills for protocols, validation plans, SOPs, and regulatory documents.
7. Excellent cross-functional communication and project management skills.
8. Leadership ability to mentor a team of scientists.
9. Critical thinking and data-driven decision-making skills.
10. Ability to prioritize and organize workloads effectively.
11. Effective interaction with interdisciplinary teams and excellent English communication skills.
12. Strategic thinking with attention to detail aligning with company and regulatory goals.

Additional Information

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industry: Medical Equipment Manufacturing