Quality Control Documentation Specialist

Job Description

• Support the QC team in maintaining compliance with applicable cGMP, FDA, USP, ICH, GDP, and internal quality procedures.
• Provide remote support for day-to-day QC documentation activities, including reviewing records, following up on pending items, tracking investigations, and coordinating document workflows.
• Review laboratory documentation such as analytical worksheets, test results, logbooks, chromatograms, calculations, electronic records, and other QC records for completeness, accuracy, and compliance with approved procedures.
• Review analytical data to ensure results are properly documented, traceable, scientifically sound, and meet applicable data integrity requirements.
• Support and, when appropriate, lead laboratory investigations related to OOS, OOT, deviations, laboratory errors, non-conformances, and atypical results.
• Work with QC analysts and other functions to understand investigation findings, identify potential root causes, perform appropriate impact assessments, and develop effective CAPA.
• Prepare and review investigation reports and ensure that investigations are completed with appropriate supporting documentation and within established timelines.
• Draft, review, and update QC documents, including SOPs, test methods, specifications, protocols, reports, forms, and other controlled documents.
• Review analytical testing records, including applicable HPLC/UPLC, GC, UV, FTIR, dissolution, particulate, microbiology, and other laboratory data, based on assigned responsibilities.
• Review applicable electronic records and audit trails to support investigations and data-review activities.
• Work closely with Quality Assurance, Manufacturing, Engineering, R&D, Validation, and Microbiology teams to support investigations, document changes, and quality-related activities.
• Track open investigations, documentation activities, CAPAs, and other QC quality-system actions to help ensure timely completion.
• Review investigation and documentation trends to identify recurring laboratory issues, documentation gaps, and opportunities for improvement.
• Provide support with electronic quality systems, including document management, training systems, investigation/CAPA tracking systems, and other applicable quality systems.
• Support the preparation and review of QC documentation required for internal audits, customer audits, regulatory inspections, and management reviews.
• Assist with training related to GDP, data integrity, QC documentation, OOS/OOT investigations, deviations, CAPA, and laboratory procedures.
• Work with QC leadership to prioritize documentation and investigation activities and ensure important quality-related tasks are completed on time.
• Serve as a remote QC point of contact for documentation and investigation follow-up activities when assigned by QC management.
• Perform other QC documentation and quality-related responsibilities as assigned by QC management.

Qualifications and Experience

• Bachelor's or masters degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or a related field.
• Typically, 5+ years of experience in pharmaceutical Quality Control, with strong experience in QC documentation and laboratory investigations.
• Good working knowledge of cGMP, FDA requirements, USP, ICH guidelines, GDP, and data integrity principles.
• Experience with OOS/OOT investigations, deviations, CAPA, laboratory errors, and analytical data review.
• Strong understanding of analytical laboratory practices and common pharmaceutical testing techniques.
• Experience reviewing HPLC/UPLC, GC, UV, FTIR, and other analytical data is preferred.
• Experience working with electronic quality/document management systems is preferred.
• Strong written and verbal communication skills.
• Ability to work independently in a remote environment and effectively communicate with teams working in different locations/time zones.
• Strong attention to detail, organizational skills, and ability to manage multiple documentation and investigation activities simultaneously.

What We Are Looking For

We are looking for someone who can understand the science behind QC activities, not just review documents. The ideal candidate should be comfortable reviewing analytical data, asking the right questions during investigations, identifying documentation or compliance gaps, and working with different teams to bring quality activities to completion.