Job Title
Senior Quality Specialist, Customer Quality & Data Integrity
Job Description
The Senior Quality Specialist, Customer Quality & Data Integrity is an experienced Quality individual contributor responsible for independent review of analytical and microbiological laboratory data and for completion of assigned Quality Assurance deliverables supporting batch disposition, customer programs, and project execution in a cGMP pharmaceutical environment. The role provides day-to-day execution support to the Senior Quality Assurance, Customer & Project Lead team by ensuring that QC laboratory records, investigations, change controls, and supporting documentation are complete, accurate, scientifically sound, traceable, and ready for Quality approval and customer commitments.
The position builds on the technical foundation of a Senior QC Analyst while shifting primary accountability from routine testing to Quality review, documentation assessment, issue follow-up, and timely closure of assigned deliverables. The reviewer applies independent Quality judgment within approved procedures, maintains separation from work personally performed when required, and escalates significant product, patient, compliance, data-integrity, customer, or schedule risks to management.
Regulatory and corporate requirements: Adhere to applicable FDA requirements, 21 CFR Parts 210, 211, and 11 as applicable, EU GMP, USP/EP requirements, ICH guidance, approved site procedures, and corporate Quality, safety, health, and environmental policies.
Values: Demonstrate integrity, scientific rigor, transparency, ownership, respectful challenge, customer focus, and Piramal Pharma Solutions standards of ethical conduct.KEY ACCOUNTABILITIES
QC Laboratory Data Review: 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. Verify completeness, accuracy, legibility, traceability, procedural compliance, and consistency across source records and reported results.
Analytical Data Review: 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. Confirm that reported results are supported by complete and scientifically valid source data.
Microbiology Data Review: 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. Obtain qualified microbiology subject-matter support when interpretation exceeds the reviewer's qualification.
Electronic Data and Data Integrity: 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. Apply ALCOA+ principles and promptly escalate potential data-integrity concerns.
QA Batch Record and Disposition Support: Complete the QC laboratory-data portion of QA batch-record review. Confirm that required testing is complete, results meet approved specifications, laboratory events are identified and resolved or appropriately assessed, certificates and supporting documentation are accurate, and open items affecting disposition are clearly documented and escalated. Provide a concise, traceable review status to the assigned Senior QA Customer & Project Lead.
Process and Laboratory Investigations: Review and, when assigned, approve laboratory investigations, OOS/OOT events, deviations, nonconformances, and process investigations. Evaluate problem statements, evidence, hypotheses, root-cause analysis, product and data impact, prior history, conclusions, CAPAs, and effectiveness checks. Confirm that conclusions are scientifically justified and that unsupported attribution to analyst or laboratory error is not accepted.
Change Control and Customer Deliverables: Draft, coordinate, complete, or review assigned customer change controls and supporting documentation. Verify the description, rationale, risk and impact assessment, affected products and documents, customer notification or approval requirements, implementation evidence, and closure package. Track customer inputs and commitments to completion in coordination with the Senior QA Customer & Project Lead.
Customer and Project Quality Support: Support preparation of customer updates, data packages, investigation summaries, change-control responses, batch-release status, action logs, meeting follow-ups, and requested evidence. Ensure communications are factual, consistent with approved records, and routed through designated Quality and project leads.
Quality Event and CAPA Follow-up: 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. Identify aging or at-risk items early and escalate obstacles that could affect batch release, customer milestones, or compliance commitments.
Documentation and Inspection Readiness: Create and maintain complete, accurate, contemporaneous, attributable, and traceable records in approved systems. Ensure review comments, resolutions, approvals, trackers, correspondence, and evidence packages are inspection-ready and retrievable.
Metrics and Continuous Improvement: Track review cycle time, right-first-time performance, recurring documentation errors, investigation quality, change-control aging, and customer deliverable status. Use trends and lessons learned to recommend improvements to checklists, procedures, training, and review practices.
Training and Technical Support: Provide coaching to QC analysts and peers on data-review expectations, Good Documentation Practices, data integrity, investigation quality, and recurring errors. Maintain required qualifications and support procedure or checklist development.
Workload Ownership and Escalation: Independently manage multiple concurrent reviews and deadlines, communicate constraints early, provide transparent status updates, and seek timely decisions when priorities conflict. Escalate actual or potential product, patient, regulatory, data-integrity, customer, or schedule risks promptly.
Laboratory Support: As business needs require and within current qualification, provide limited technical support for laboratory troubleshooting, protocols, reports, method-related questions, or testing activities. Routine testing is secondary to assigned Quality data-review and project-support responsibilities and must not compromise reviewer independence.
DECISION RIGHTS AND ROLE BOUNDARIES
• Approve or reject QC data packages and assigned Quality records within documented training, qualification, procedural authority, and approved workflows.
• Return incomplete or noncompliant records for correction and require objective evidence before approval.
• Place a review on hold and escalate when data are incomplete, contradictory, unexplained, potentially noncompliant, or present a possible product or data-integrity risk.
• Does not independently release or disposition a batch unless separately authorized by procedure and delegated in writing.
• Does not approve work personally performed when independence or segregation of duties is required.
• Does not make commitments to customers outside approved communication channels or without alignment from the designated Senior QA Customer & Project Lead or management.
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; role-specific qualification must be completed before independent approval.
• 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.
PHYSICAL DEMANDS AND WORK ENVIRONMENT
Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions.
• Extended periods of sitting, standing, walking, typing, computer use, data review, and virtual or in-person meetings may be required.
• Work may include exposure to laboratory, manufacturing, warehouse, or controlled environments.
• Required personal protective equipment may include safety glasses, lab coats, gloves, specialized clothing, and appropriate footwear.
• Occasional lifting, bending, stooping, squatting, pushing, or pulling may be required.
