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Sellersville, Pennsylvania, United States
Onsite
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Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Sr. Quality Specialist, Laboratory Investigations & Data IntegrityJob Description
POSITION SUMMARYKEY ACCOUNTABILITIES
• Laboratory Investigation Ownership: Lead, author, coordinate, and complete laboratory investigations involving OOS, OOT, atypical, invalid, questionable, or unexpected results and laboratory-related deviations. Establish a clear investigation plan, preserve relevant evidence, meet approved timelines, and escalate potential product, patient, regulatory, or data-integrity risks promptly.
• Phase I Laboratory Assessment: Conduct and document prompt laboratory assessments that evaluate analyst execution, calculations, sample and standard preparation, reagents and solutions, method requirements, instrument condition, system suitability, chromatograms, integration, processing parameters, environmental conditions, maintenance, calibration, and other relevant laboratory controls. Avoid attributing results to laboratory error without documented scientific evidence.
• Full-Scale Investigation Support: When a conclusive laboratory root cause is not established, coordinate with QA, Manufacturing, Technical Services, Regulatory Affairs, and other functions to support an expanded investigation of manufacturing, sampling, materials, methods, and prior history. Ensure laboratory data and conclusions are clearly incorporated into product-impact and batch-disposition decisions.
• OOS/OOT Governance: Maintain active oversight of assigned OOS/OOT records from initiation through closure. Ensure original results are preserved and reported, hypotheses are predefined and scientifically justified, and any retesting, resampling, averaging, reintegration, or additional testing is performed only under approved procedures and documented protocols.
• Root Cause Analysis: Apply structured root-cause tools and scientific critical thinking to distinguish assignable cause, contributing factors, systemic causes, method variability, instrument or system issues, sampling issues, and potential manufacturing causes. Document evidence supporting or refuting each hypothesis and ensure conclusions are commensurate with the available facts.
• CAPA Development and Effectiveness: Develop risk-based corrective and preventive actions that address confirmed root and contributing causes. Define responsible owners, deliverables, due dates, interim controls, and measurable effectiveness checks. Track assigned CAPAs to timely completion and evaluate whether actions achieved sustained correction without creating new risk.
• Analytical Data Review: Perform independent, comprehensive review of raw data and reported results for routine, release, stability, validation, transfer, and investigation testing. Verify sample identity, specifications, methods, calculations, dilution factors, significant figures, transcriptions, system suitability, sequence suitability, integration, result reporting, and consistency between source data, worksheets, LIMS, certificates, and reports.
• Electronic Data and Metadata Review: Review complete electronic records, relevant metadata, sequence information, processing histories, audit trails, deleted or aborted injections, reinjections, reprocessing, reintegration, manual entries, date and time information, user actions, and unexplained or unreported data. Confirm that the record permits reconstruction of the analytical activity and that changes are authorized, justified, attributable, and retained.
• Data Integrity Compliance: Apply ALCOA+ principles to paper, electronic, and hybrid laboratory records. Identify vulnerabilities involving data generation, acquisition, processing, review, transfer, storage, backup, retrieval, archival, access, or deletion and initiate escalation, investigation, interim controls, and remediation when concerns are identified.
• Audit Trail Review: Execute and document risk-based audit-trail reviews for applicable laboratory systems. Assess critical changes and events before data are used for Quality decisions, investigate discrepancies, and support periodic or targeted reviews to verify continued effectiveness of laboratory data controls.
• Laboratory Systems and Controls: Partner with QC management, QA, IT, validation, metrology, and system owners to evaluate laboratory computerized systems, user access, segregation of duties, time synchronization, method and processing controls, data paths, interfaces, backup and archival arrangements, and system limitations. Recommend procedural or technical controls based on data criticality and risk.
• Method and Instrument Technical Assessment: Use advanced knowledge of HPLC and other laboratory technologies to assess method execution and performance. Evaluate assay, impurities, dissolution, content uniformity, blend uniformity, stability, and applicable wet-chemistry or instrumental testing during investigations and data review.
• Trend Analysis and Metrics: Trend OOS/OOT events, invalidations, repeat testing, reintegration, analyst and instrument factors, recurring root causes, CAPA effectiveness, aging, and investigation cycle time. Prepare accurate dashboards and communicate significant adverse trends, overdue actions, and systemic risks to QC and Quality leadership.
• SOPs, Tools, and Continuous Improvement: Author or revise procedures, investigation templates, checklists, decision trees, data-review tools, and training materials. Use lessons learned and inspection observations to strengthen investigation quality, right-first-time documentation, data-review consistency, and laboratory controls.
• Training and Technical Mentoring: Train and mentor analysts, reviewers, and investigators on OOS/OOT requirements, investigation documentation, hypothesis testing, root-cause analysis, CAPA quality, Good Documentation Practices, electronic data review, audit trails, and data-integrity expectations. Provide technical coaching without direct supervisory responsibility.
• Inspection and Audit Readiness: Maintain investigation and data-review records in an inspection-ready state. Support customer audits, internal audits, regulatory inspections, and responses by retrieving records, explaining investigation rationale, demonstrating data traceability, and completing assigned remediation commitments.
• Cross-Functional Communication: Provide clear, factual, and timely updates to the Associate Director QC, QA, project teams, and other stakeholders. Communicate uncertainty transparently, separate facts from hypotheses, obtain SME input, and escalate conflicts, delays, repeat events, or data-integrity concerns.
• Laboratory Testing Support: As business needs require and within current qualification, perform or support analytical testing, standards and sample preparation, LIMS documentation, peer review, protocol and report preparation, and laboratory troubleshooting in accordance with approved methods and procedures.
• Workload Ownership: Independently prioritize multiple investigations, reviews, CAPAs, and improvement activities. Maintain current trackers, identify resource constraints early, and ensure deliverables are completed accurately and within approved commitments.
EDUCATION / EXPERIENCE
• Education: Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related scientific discipline is required. An advanced scientific degree is preferred.
• Laboratory Experience: Minimum five (5) years of pharmaceutical Quality Control laboratory experience in a GMP-regulated environment, including independent analytical testing and data review.
• Investigation Experience: Demonstrated experience authoring or leading laboratory investigations, including OOS/OOT assessments, hypothesis testing, root-cause analysis, product-impact evaluation, CAPA development, and effectiveness verification.
• Analytical Expertise: Hands-on experience with HPLC and applicable techniques such as GC, dissolution, UV-Vis, FTIR, Karl Fischer, pH, particle-size analysis, XRD, wet chemistry, titration, viscosity, conductivity, or other compendial testing.
• Data Integrity: Demonstrated ability to review electronic raw data, metadata, chromatographic processing, audit trails, LIMS records, and hybrid records in accordance with ALCOA+ and cGMP data-integrity expectations.
• Regulatory Knowledge: Strong working knowledge of FDA OOS and data-integrity guidance, 21 CFR Parts 210 and 211, 21 CFR Part 11 as applicable, USP/EP requirements, Good Documentation Practices, and scientifically sound investigation principles.
• Systems: Experience with laboratory systems such as LIMS, chromatography data systems, electronic QMS, SAP, instrument software, or comparable platforms is preferred.
• CDMO Experience: Experience supporting multiple products, customers, methods, and concurrent priorities in a CDMO/CMO environment is preferred.
JOB COMPETENCIES
• Advanced scientific investigation, critical-thinking, root-cause analysis, and technical-writing capability.
• High attention to detail and ability to critically review complex paper and electronic analytical records.
• Sound, independent Quality judgment with willingness to question unsupported conclusions and escalate risk.
• Ability to separate facts, observations, hypotheses, and conclusions and communicate each clearly.
• Strong knowledge of chromatography, laboratory controls, OOS/OOT principles, CAPA systems, and data-integrity expectations.
• Ability to influence and coordinate analysts, laboratory leadership, QA, IT, validation, and cross-functional SMEs without direct authority.
• Strong organization, prioritization, and follow-through across multiple time-sensitive investigations and reviews.
• Clear written, verbal, presentation, and inspection-interaction skills.
• Commitment to transparent reporting, patient and product protection, and an open Quality culture.
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, electronic data review, and document review may be required.
• Work includes routine presence in Quality Control laboratory areas and limited exposure to manufacturing and warehouse environments.
• Required personal protective equipment may include safety glasses, lab coats, gloves, specialized clothing, and appropriate footwear.
• Handling of laboratory chemicals, standards, samples, glassware, and analytical equipment may be required in accordance with approved safety procedures.
• Occasional lifting, bending, stooping, squatting, pushing, or pulling may be required.
EMPLOYEE ACKNOWLEDGEMENT
I have read and understand the essential duties and requirements of this job description. This document is not intended to be an exhaustive list of all duties, and responsibilities may be modified to meet business needs.
