Sr. QC Analyst - Stability
Piramal Pharma Solutions
Summary
The Senior QC Analyst - Stability is responsible for supporting and executing the site's Stability Program through the testing, monitoring, tracking, and documentation of stability samples in accordance with cGMP requirements, approved protocols, ICH guidelines, and regulatory commitments. This role performs analytical testing of stability samples, evaluates stability data and trends, coordinates stability studies, supports laboratory investigations, and ensures on-time execution of the site's stability program. The Senior QC Analyst serves as a subject matter expert for stability activities and partners with Quality Control, Quality Assurance, Regulatory Affairs, and Operations to maintain compliance and support product lifecycle management.
Job description
Essential Responsibilities
- Coordinate and execute stability studies in accordance with approved protocols, regulatory commitments, and ICH guidelines.
- Perform analytical testing of stability samples utilizing HPLC, UPLC, GC, dissolution, and other laboratory instrumentation.
- Monitor stability sample inventories, pull schedules, storage conditions, and testing timelines to ensure on-time completion.
- Review, trend, and evaluate stability data to identify Out-of-Trend (OOT) results and emerging quality concerns.
- Generate and maintain stability study documentation, sample inventories, protocols, summary reports, and supporting records.
- Perform data review and verification activities to support product release and annual product quality reviews.
- Lead and support laboratory investigations, including OOS, OOT, atypical, and stability-related deviations.
- Support stability program inspections, regulatory audits, and customer audits.
- Maintain stability chambers and support temperature mapping, qualification, monitoring, and alarm management activities.
- Support method validation, verification, method transfers, and continuous improvement initiatives.
- Train and mentor QC Analysts on stability-related procedures, testing techniques, and regulatory requirements.
- Ensure compliance with cGMP, GDP, data integrity requirements, and site procedures.
Experience
- Minimum 7 years of Quality Control laboratory experience within the pharmaceutical, biotechnology, or related regulated industry.
- Minimum 3 years of direct experience supporting pharmaceutical stability programs.
- Demonstrated experience performing stability testing and managing stability studies in a cGMP environment.
- Experience reviewing and trending stability data and supporting stability-related investigations.
- Experience with analytical instrumentation including HPLC, UPLC, GC, and dissolution systems.
- Experience authoring or reviewing stability protocols and stability reports preferred.
- Experience supporting regulatory inspections and customer audits preferred.
Knowledge, Skills & Abilities
- Strong understanding of pharmaceutical stability programs and ICH stability guidelines (Q1A through Q1E).
- Strong analytical chemistry and laboratory investigation skills.
- Expertise with HPLC, UPLC, GC, dissolution, and associated analytical methodologies.
- Experience interpreting long-term, accelerated, and ongoing stability data.
- Knowledge of OOS, OOT, deviations, CAPAs, and change control processes.
- Proficiency with Empower, LIMS, TrackWise, and electronic quality systems.
- Strong data analysis, trend evaluation, and technical writing skills.
- Ability to manage multiple stability studies and competing priorities in a fast-paced environment.
- Strong communication and collaboration skills across Quality, Regulatory Affairs, Manufacturing, and Technical Services.
Requirements
- Minimum 7 years of Quality Control laboratory experience within the pharmaceutical, biotechnology, or related regulated industry
- Minimum 3 years of direct experience supporting pharmaceutical stability programs
- Demonstrated experience performing stability testing and managing stability studies in a cGMP environment
- Experience reviewing and trending stability data and supporting stability-related investigations
- Experience with analytical instrumentation including HPLC, UPLC, GC, and dissolution systems
- Strong understanding of pharmaceutical stability programs and ICH stability guidelines (Q1A through Q1E)
- Strong analytical chemistry and laboratory investigation skills
- Expertise with HPLC, UPLC, GC, dissolution, and associated analytical methodologies
- Experience interpreting long-term, accelerated, and ongoing stability data
- Knowledge of OOS, OOT, deviations, CAPAs, and change control processes
- Proficiency with Empower, LIMS, TrackWise, and electronic quality systems
- Strong data analysis, trend evaluation, and technical writing skills
- Ability to manage multiple stability studies and competing priorities in a fast-paced environment
- Strong communication and collaboration skills across Quality, Regulatory Affairs, Manufacturing, and Technical Services
Company overview
Piramal Pharma Solutions (PPS) is a leading global Contract Development and Manufacturing Organization (CDMO) offering comprehensive end-to-end solutions across the entire drug lifecycle. As part of Piramal Pharma Limited, the company operates through a globally integrated network of 15 facilities across North America, Europe, and Asia, serving over 500 customers worldwide. PPS provides a complete range of services including drug discovery solutions, process and pharmaceutical development, clinical trial supplies, and commercial manufacturing of APIs and finished dosage forms. The company specializes in advanced technologies such as antibody-drug conjugates (ADCs), highly potent APIs, sterile fill/finish, peptide products, and potent solid oral drug products. With a team of over 4,700 professionals and a strong track record of regulatory compliance, Piramal Pharma Solutions has established itself as a trusted partner for both innovator and generic pharmaceutical companies, delivering patient-centric solutions with a focus on quality, operational excellence, and innovation.