Quality Control Sr Analyst

piramalpharma; Sellersville (Bucks County); On-site; USD 90,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Quality Specialist, Laboratory Investigations & Data Integrity, to lead and complete investigations, OOS/OOT assessments, CAPA development, and review analytical data in a cGMP lab. This role requires scientific judgment and timely action to closure.

You will review analytical testing of raw materials, finished products, stability samples, and special requests, ensuring data integrity, traceability, and regulatory compliance in a fast-paced

Qualifications

• Regulatory and corporate requirements: Adhere to FDA guidance and cGMP expectations.
• Values: integrity, scientific rigor, transparency, ownership, respectful challenge.

Responsibilities

• Laboratory Investigation Ownership: Lead and complete investigations (OOS/OOT) and CAPA development.
• Review of analytical data: Independent review of raw data, chromatograms, and narratives for traceability and compliance.
• OOS/OOT governance: Maintain oversight of records from initiation to closure and ensure proper documentation.

Job description

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

Quality Control Sr 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.

• 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.

KEY 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 escalation 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 routin