Sr. Quality Specialist, Laboratory Investigations & Data Integrity

Piramal Pharma Ltd•Sellersville, PA

About The Position

The Senior Quality Specialist, Laboratory Investigations & Data Integrity is an experienced Quality Control individual contributor responsible for leading and completing laboratory investigations, OOS/OOT assessments, CAPA development, and comprehensive analytical data review in a cGMP pharmaceutical laboratory. Reporting to the Associate Director, Quality Control, this role applies scientific and regulatory judgment to determine root cause, assess product and data impact, document defensible conclusions, and drive timely actions to closure. The role builds on a Senior QC Analyst technical foundation and requires the ability to understand and evaluate analytical testing of raw materials, finished products, stability samples, and special-request samples. The specialist independently reviews paper and electronic laboratory records, chromatographic data, calculations, metadata, audit trails, instrument outputs, and LIMS entries for completeness, accuracy, traceability, procedural compliance, and data integrity. The position also contributes to laboratory testing as business needs require, develops and improves procedures and review tools, mentors analysts and investigators without direct supervisory responsibility, and supports audit and inspection readiness. The work includes routine presence in Quality Control laboratory areas and limited exposure to manufacturing and warehouse environments. Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions.

Requirements

Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related scientific discipline.
At least five years of pharmaceutical Quality Control laboratory experience in a GMP-regulated environment, including independent analytical testing and data review.
Demonstrated experience authoring or leading laboratory investigations, including OOS/OOT assessments, hypothesis testing, root-cause analysis, product-impact evaluation, CAPA development, and effectiveness verification.
Hands-on HPLC experience and experience with 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.
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.
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.
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, including willingness to question unsupported conclusions and escalate risk.
Ability to clearly distinguish and communicate facts, observations, hypotheses, and conclusions.
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.
Ability to perform essential job functions, with reasonable accommodations available where applicable; the role may require handling laboratory chemicals, standards, samples, glassware, and analytical equipment under approved safety procedures.

Nice To Haves

An advanced scientific degree.
Experience with laboratory systems such as LIMS, chromatography data systems, electronic QMS, SAP, instrument software, or comparable platforms.
Experience supporting multiple products, customers, methods, and concurrent priorities in a CDMO/CMO environment.

Responsibilities

Lead, author, coordinate, and complete laboratory investigations involving OOS, OOT, atypical, invalid, questionable, or unexpected results and laboratory-related deviations; establish investigation plans, preserve evidence, meet timelines, and promptly escalate risks.
Conduct and document Phase I laboratory assessments, evaluating analyst execution, calculations, sample and standard preparation, reagents, methods, instruments, system suitability, chromatograms, environmental conditions, maintenance, calibration, and other relevant controls.
Coordinate expanded investigations with QA, Manufacturing, Technical Services, Regulatory Affairs, and other functions when laboratory root cause is inconclusive; incorporate laboratory findings into product-impact and batch-disposition decisions.
Oversee assigned OOS/OOT records through closure, ensuring original results are preserved and reported and that hypotheses and any retesting, resampling, averaging, reintegration, or additional testing are scientifically justified and properly approved and documented.
Apply structured root-cause analysis to distinguish assignable causes, contributing and systemic factors, method variability, instrument or system issues, sampling issues, and potential manufacturing causes; document evidence for and against each hypothesis.
Develop risk-based CAPAs with owners, deliverables, due dates, interim controls, and measurable effectiveness checks; track actions and assess whether they achieve sustained correction without creating new risk.
Independently review analytical raw data and reported results for routine, release, stability, validation, transfer, and investigation testing, checking sample identity, specifications, methods, calculations, dilution factors, transcriptions, system suitability, integration, and consistency across records and reports.
Review electronic records and metadata, including sequence and processing histories, audit trails, deleted or aborted injections, reinjections, reprocessing, reintegration, manual entries, timestamps, user actions, and unexplained or unreported data.
Apply ALCOA+ principles to paper, electronic, and hybrid records; identify data-integrity vulnerabilities and initiate escalation, investigation, interim controls, and remediation as needed.
Conduct and document risk-based audit-trail reviews, assess critical changes and events before data are used for Quality decisions, investigate discrepancies, and support periodic or targeted review.
Partner with QC management, QA, IT, validation, metrology, and system owners to assess laboratory computerized systems and controls, including access, segregation of duties, time synchronization, methods, data paths, interfaces, backup, archival, and system limitations.
Use advanced knowledge of HPLC and other laboratory technologies to assess method execution and performance, including testing such as assay, impurities, dissolution, content uniformity, blend uniformity, and stability testing.
Trend OOS/OOT events, invalidations, repeat testing, reintegration, analyst and instrument factors, recurring causes, CAPA effectiveness, aging, and investigation cycle time; prepare dashboards and communicate significant trends and risks.
Author or revise procedures, investigation templates, checklists, decision trees, data-review tools, and training materials to improve investigation quality, documentation, review consistency, and laboratory controls.
Train and mentor analysts, reviewers, and investigators on OOS/OOT requirements, documentation, hypothesis testing, root-cause analysis, CAPA, Good Documentation Practices, electronic data review, audit trails, and data integrity.
Maintain inspection-ready investigation and data-review records; support customer and internal audits, regulatory inspections, record retrieval, explanations of investigation rationale, and remediation commitments.
Provide clear and timely updates to the Associate Director QC, QA, project teams, and stakeholders; communicate uncertainty, distinguish facts from hypotheses, obtain SME input, and escalate conflicts, delays, repeat events, or data-integrity concerns.
Perform or support analytical testing, standards and sample preparation, LIMS documentation, peer review, protocol and report preparation, and laboratory troubleshooting as business needs require and within current qualification.
Independently prioritize investigations, reviews, CAPAs, and improvement activities; maintain trackers, identify resource constraints, and complete deliverables accurately within approved commitments.