Senior Quality Specialist, Customer Quality & Data Integrity

Key Accountabilities

• Perform independent review of analytical chemistry and microbiology records supporting raw materials, in-process materials, finished products, stability samples, cleaning verification/validation, methods, transfers, validations, and investigations.
• Review worksheets, notebooks, instrument outputs, chromatograms, calculations, dilution factors, standards, reagents, sample preparations, system suitability, sequences, integration, processing parameters, specifications, LIMS entries, certificates, protocols, and reports.
• Review microbiology testing and associated records, including sample identification, media and reagent controls, incubation conditions, growth promotion and suitability requirements, colony counts or observations, calculations, environmental or utility monitoring data as assigned, method requirements, specifications, LIMS entries, and final reporting.
• Review applicable electronic records, metadata, audit trails, sequence activity, reprocessing, reintegration, repeat testing, aborted runs, manual entries, user actions, date/time information, and unexplained or unreported data in accordance with approved procedures.
• Complete the QC laboratory-data portion of QA batch-record review.
• Review and, when assigned, approve laboratory investigations, OOS/OOT events, deviations, nonconformances, and process investigations.
• Draft, coordinate, complete, or review assigned customer change controls and supporting documentation.
• Support preparation of customer updates, data packages, investigation summaries, change-control responses, batch-release status, action logs, meeting follow-ups, and requested evidence.
• Maintain assigned trackers and follow up with QC, Manufacturing, Technical Services, Validation, Regulatory Affairs, and other functions for corrections, investigation inputs, CAPA evidence, and approvals.
• Create and maintain complete, accurate, contemporaneous, attributable, and traceable records in approved systems.
• Track review cycle time, right-first-time performance, recurring documentation errors, investigation quality, change-control aging, and customer deliverable status.
• Provide coaching to QC analysts and peers on data-review expectations, Good Documentation Practices, data integrity, investigation quality, and recurring errors.
• Independently manage multiple concurrent reviews and deadlines, communicate constraints early, provide transparent status updates, and seek timely decisions when priorities conflict.

Education / Experience

• Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Life Sciences, or a related scientific discipline is required.
• Minimum five (5) years of experience in a pharmaceutical, biotechnology, or regulated life-sciences environment, including substantial experience in a cGMP QC laboratory or Quality function.
• Demonstrated experience reviewing analytical laboratory data is required.
• Experience reviewing microbiology data is strongly preferred.
• Working experience with batch records, laboratory investigations, OOS/OOT events, deviations, change controls, CAPAs, and product-impact assessments is preferred.
• Working knowledge of 21 CFR Parts 210 and 211, 21 CFR Part 11 as applicable, EU GMP, USP/EP requirements, data-integrity expectations, Good Documentation Practices, and risk-based Quality decision-making.
• Experience with laboratory and Quality systems such as LIMS, chromatography data systems, electronic document systems, TrackWise, MasterControl, Veeva, SAP, or comparable platforms is preferred.
• Experience supporting multiple products, customers, and concurrent deliverables in a CDMO/CMO environment is preferred.

Job Competencies

• Advanced attention to detail with the ability to reconstruct testing and identify inconsistencies across paper, electronic, and hybrid records.
• Sound scientific judgment and the confidence to challenge incomplete evidence, unsupported conclusions, or noncompliant practices respectfully.
• Strong knowledge of analytical testing concepts; sufficient microbiology knowledge to review within qualification and recognize when specialized expertise is required.
• Effective investigation review, root-cause analysis, technical writing, risk assessment, and problem-solving skills.
• Ability to prioritize batch-release needs, customer commitments, investigations, change controls, and project deadlines without compromising Quality standards.
• Clear written and verbal communication, reliable follow-through, and effective coordination across QC, QA, Manufacturing, Technical Services, Validation, Regulatory Affairs, Supply Chain, and Project Management.
• Proficiency in Microsoft Word, Excel, PowerPoint, and preparation of accurate trackers, dashboards, and inspection-ready documentation.
• Ability to work independently in a changing, deadline-driven environment while maintaining confidentiality, accuracy, and compliance.