Senior Quality Control Analyst

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 90,000 - 130,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Quality Control Analyst to lead investigations, assess data integrity, and ensure regulatory compliance in a cGMP laboratory. The role focuses on OOS/OOT investigations, CAPA development, and comprehensive review of analytical data.

Reporting to QC leadership, you will review chromatograms, LIMS data, and instrument outputs, drive timely closure of investigations, and partner with QA, Regulatory Affairs, and Manufacturing.

Qualifications

• Experience leading laboratory investigations and data reviews.
• Strong understanding of OOS/OOT and CAPA processes.
• Familiarity with data integrity principles and ALCOA+.

Responsibilities

• Lead laboratory investigations for OOS/OOT events and deviations.
• Coordinate root-cause analyses and CAPA plans.
• Review raw data, chromatograms, and audit trails for compliance.
• Ensure data integrity and regulatory readiness for inspections.
• Collaborate with QA, Regulatory, and manufacturing teams.

Skills

Laboratory investigations

OOS/OOT analysis

CAPA development

Data integrity

HPLC analysis

Analytical data review

Education

Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biology, Microbiology, or related field

Tools

LIMS

Chromatography instrumentation

Job description

Be the First to Apply Division Piramal Pharma Solutions 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. For more details, please visit : www.piramalpharmasolutions.com

Job Title Senior Quality Control Analyst

Job Description

POSITION SUMMARY

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.

KEY ACCOUNTABILITIES

• Regulatory and corporate requirements: Adhere to applicable FDA requirements and guidance, 21 CFR Parts 210, 211, and 11 as applicable, USP/EP compendial requirements, ICH guidance, approved site procedures, and corporate Quality, safety, health, and environmental policies.
• Values: Consistently demonstrate integrity, scientific rigor, transparency, ownership, respectful challenge, and Piramal Pharma Solutions standards of ethical conduct.
• 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 escape 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 elevate 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.