Quality Control Analyst

Piramal Pharma • Sellersville, PA

23h • Onsite

About The Position

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO) that provides comprehensive development and manufacturing solutions throughout the drug lifecycle. They operate a globally integrated network of facilities across North America, Europe, and Asia, offering services such as Drug Discovery Solutions, Process & Pharmaceutical Development, Clinical Trial Supplies, and Commercial supply of APIs and Finished dosage forms. They also specialize in the development and manufacturing of Highly Potent APIs and Antibody Drug Conjugation. Their integrated service model and technological expertise cater to both Innovator and Generic companies worldwide.

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.

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.
• 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.
• Coordinate with QA, Manufacturing, Technical Services, Regulatory Affairs, and other functions to support an expanded investigation of manufacturing, sampling, materials, methods, and prior history when a conclusive laboratory root cause is not established.
• Maintain active oversight of assigned OOS/OOT records from initiation through closure.
• 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.
• Develop risk-based corrective and preventive actions that address confirmed root and contributing causes.
• Perform independent, comprehensive review of raw data and reported results for routine, release, stability, validation, transfer, and investigation testing.
• 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.
• Apply ALCOA+ principles to paper, electronic, and hybrid laboratory records.
• Execute and document risk-based audit-trail reviews for applicable laboratory systems.
• 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.
• Use advanced knowledge of HPLC and other laboratory technologies to assess method execution and performance.
• Trend OOS/OOT events, invalidations, repeat testing, reintegration, analyst and instrument factors, recurring root causes, CAPA effectiveness, aging, and investigation cycle time.
• Author or revise procedures, investigation templates, checklists, decision trees, data-review tools, and training materials.
• 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.
• Maintain investigation and data-review records in an inspection-ready state.
• Provide clear, factual, and timely updates to the Associate Director QC, QA, project teams, and other stakeholders.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior