Remote Senior Data Review Specialist - Chemistry (Data Review)

Description:

• The Senior Data Review Specialist – Chemistry ensures the integrity, accuracy, and compliance of scientific data while supporting critical laboratory operations.
• In this role, you will review complex analytical results, validate calculations, and assess data against regulatory and methodological standards, ensuring high-quality outputs.
• You will collaborate closely with laboratory personnel and internal clients, providing guidance and resolving data-related issues.
• This position demands a detail-oriented and scientifically rigorous mindset, combining technical expertise with clear communication skills.
• Your work will directly influence the reliability of laboratory reporting and regulatory compliance.
• You will apply GMP/GLP principles consistently in all areas of responsibility.
• You will review simple and complex routine and non-routine data across multiple areas according to departmental, corporate, and client SOPs.
• You will evaluate laboratory documentation, analytical procedures, calculated results, and final reports for accuracy, clarity, and regulatory compliance.
• You will communicate findings and recommendations clearly to laboratory personnel and internal clients.
• You will perform complex calculations, integration reviews, and compound evaluations to ensure data is compliant and defensible.
• You will serve as a technical advisor for analysts regarding QA/QC of data and support process improvement initiatives.
• You will stay updated on professional trends and internal procedures, contributing to SOP development and training of new and existing team members.

Requirements:

• A Master’s degree in a science-related field is required, with 7–10 years of experience in bio-pharmaceutical chemistry, drug product/substance testing, and data review responsibilities.
• A strong understanding of regulatory requirements and laboratory best practices is essential.
• Experience with analytical techniques and data review, including pH measurement, XRD, KF, chromatography (HPLC/UPLC, GC, IC), and other relevant methods is necessary.
• Proficiency with laboratory software, such as Waters Empower, LIMS, and Electronic Notebooks is required.
• Excellent attention to detail, logical thinking, and strong analytical and mathematical skills are needed.
• Effective written and verbal communication skills to interact with colleagues and clients are essential.
• The ability to handle multiple tasks, prioritize work, and learn new procedures quickly is required.
• A demonstrated ability to coach and mentor peers is necessary.

Benefits:

• The position offers a competitive salary and potential for career growth.
• A flexible work environment with opportunities to collaborate with global teams is provided.
• Professional development and training opportunities are available.
• Exposure to advanced analytical methods and cutting-edge laboratory technologies is included.
• A collaborative and scientifically rigorous work culture is fostered.
• Health and wellness benefits are offered as applicable per local policy.