Data Reviewer, Quality Control

The Position

The Data Reviewer is responsible for ensuring the accuracy, completion, quality, and compliance of laboratory data and reports produced within the Quality Control (QC) team. Key functions of this position include the technical review of internal and external analytical testing data, related documentation, validations, and reports to ensure compliance with analytical methods and specifications. In addition, this position will also be responsible for authoring laboratory investigations (invalidations, out-of-specifications) with input from analysts manage deadlines for review completion and aid in the organization and maintenance of data. The ideal candidate will have demonstrated experience with analytical testing, either in performance or technical review. 

Responsibilities: 

• Evaluate data and reports from external testing laboratories and CDMOs to ensure compliance with specifications and Good Documentation Practices (GDP) and adherence to Data Integrity requirements.
• Ensure documentation, data, and records are complete, accurate, and maintained in a state of inspection readiness to support business needs and regulatory audits.
• Understand and acquire knowledge to effectively navigate associated laboratory software systems and equipment interfaces, enabling thorough and technically sound record review.
• Support internal and external audits, including audit preparation activities and direct support during inspections.
• Review reagent and equipment logbooks to verify traceability, compliance, and operational consistency.
• Author lab investigations in relation to invalid or out-of-specification results (with input from analysts).
• Utilize strong investigative skills to identify, assess, and resolve issues within laboratory operations, driving effective root cause analysis and corrective actions.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure full compliance with regulatory and internal requirements.
• Work directly with management to ensure QC goals and milestones are met, proactively identifying risks and mitigation strategies.
• Complete all required training and assigned learning plans according to defined due dates and prescribed requalification cadence.
• Embrace digital tools and opportunities to leverage advanced analytics and generative AI enabled solutions to enhance documentation review, trend analysis, deviation investigations, and overall laboratory performance.
• Perform additional duties as assigned in support of QC operations.

Requirements:

• Bachelor of Science in Chemistry or (any STEM degree) with minimum 7 years of experience in a cGMP laboratory (pharmaceutical CMO/CRO), or a Master of Science (STEM degree) with minimum 5 years of experience in a cGMP laboratory.
• Hands-on experience in analytical chemistry and compendial testing. Previous experience reviewing data in GMP environment for GDP/GMP compliance as well as audit trail review.
• Experience in a pharmaceutical setting; previous investigation writing and auditing experience preferred.

Preferred:

• Working knowledge of USP, ISO, FDA and ICH guidelines
• Strong knowledge of HPLC, GC, LC-MS, UV, KF, pH, Appearance, Raman, FTIR, NMR, Osmolality, Endotoxin, Bioburden etc.
• Familiarity with laboratory information systems
• Strong verbal and written communication skills and ability to work with diverse professionals in a matrix environment.
• Solid organizational skills with ability to adapt to changing priorities and deadlines.