Quality Control Analyst

Piramal Pharma Ltd•Sellersville, PA

7d•Onsite

About The Position

Piramal 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. 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 review of analytical data in a cGMP pharmaceutical laboratory. Reporting to the Associate Director, Quality Control, the 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 position builds on the Senior QC Analyst technical foundation and retains 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 to verify completeness, accuracy, traceability, procedural compliance, and data integrity.

Requirements

Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related scientific discipline is required.
Minimum five (5) 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 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.
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.
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.
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.

Nice To Haves

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

Responsibilities

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.