Job Details

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Job Title: Documentation Reviewer - Analytical Chemistry

Summary:

We are seeking an experienced professional to review analytical data, laboratory documentation, protocols, and reports to ensure compliance with established procedures, GMP standards, and regulatory guidelines. This role requires strong attention to detail, technical expertise in analytical methods, and the ability to collaborate effectively with internal teams and external partners.

Key Responsibilities:

• Review laboratory data, notebooks, worksheets, logbooks, and audit trails for accuracy and compliance.
• Assess documentation related to raw material, in-process, and finished product testing (e.g., HPLC, GC, dissolution, impurities, content uniformity, etc.).
• Ensure calculations and results are accurate, compliant, and properly transcribed to reports.
• Collaborate with internal teams and CMOs to resolve documentation issues, OOS investigations, and deviations.
• Update or draft SOPs and analytical methods as needed.
• Provide constructive feedback to minimize recurring documentation errors.

Qualifications:

• BS/BA in Chemistry or related field.
• 5+ years of analytical laboratory experience in the pharmaceutical industry.
• 2+ years of hands-on experience reviewing laboratory data and documentation.
• Proficiency with analytical techniques (HPLC, GC, UV, IR, KF, etc.) and instrument software (e.g., Empower, Chemstation, Chromeleon).
• Strong knowledge of GMP, FDA/ICH guidelines, and compendial standards.
• Excellent mathematical, organizational, and communication skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).

Why Join Us:

This is an excellent opportunity to leverage your analytical expertise and attention to detail to ensure quality and compliance in a fast-paced, collaborative environment.

Apply now to make an impact in advancing high-quality pharmaceutical products.