Quality Control Analyst II

Piramal Pharma Limited; Northern (KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Piramal Pharma Solutions in Sellersville, PA, seeks a Quality Control Analyst II to perform routine analytical testing using GC, HPLC and UPLC to support product release and stability studies. Strong chromatography skills, method compliance and GDP documentation are required.

The candidate will prepare samples, calibrate instruments, review data in Empower, investigate deviations, and collaborate with QA, Manufacturing and R&D to maintain GMP/GDP standards.

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology or related scientific discipline with relevant lab coursework.
• Minimum 2 years of laboratory experience in a GMP-regulated environment.
• Hands-on experience with wet chemistry, chromatographic analysis and instrument operation.

Responsibilities

• Perform qualitative and quantitative analysis using GC, HPLC and UPLC per approved methods and SOPs.
• Prepare samples, standards, diluents and mobile phases following established lab procedures and GDP practices.
• Execute instrument setup, calibration, and system suitability checks; maintain accurate records.
• Process, interpret and review chromatographic data using Empower or equivalent software.
• Investigate atypical results or method deviations and participate in CAPA where needed.
• Support method transfers, verifications, and validations by generating high-quality analytical data.
• Maintain laboratory readiness and ensure safety compliance and proper labeling.

Skills

GC/HPLC/UPLC

Empower software

GDP/GMP knowledge

Documentation practices

Analytical technique knowledge

Education

Bachelor's degree in Chemistry, Biology, or Microbiology

Tools

FTIR

Karl Fischer

Dissolution testing

Job description

## Quality Control Analyst IIApply: Sellersville: Full time: Posted Today: R00004127***Be the First to Apply*****Division**Piramal Pharma SolutionsPiramal 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.comJob TitleQuality Control Analyst IIJob DescriptionThe Quality Analyst II performs routine analytical testing using Liquid Chromatography (LC) and Gas Chromatography (GC) techniques in support of product release, stability and studies. This role requires strong technical competency in chromatographic analysis, sample preparation, instrument operation, data processing, and troubleshooting within a GMP/GLP laboratory environment.**Key responsibilities*** Perform qualitative and quantitative analysis using **GC, HPLC, UPLC**, and related chromatographic systems in accordance with approved test methods and SOPs.* Prepare samples, standards, diluents, and mobile phases following established laboratory procedures and good documentation practices.* Execute instrument setup, calibration, system suitability checks, and routine maintenance to ensure reliable performance.* Process, integrate, and interpret chromatographic data using software such as **Empower** or equivalent.* Review chromatograms for peak integrity, retention time consistency, baseline quality, and compliance with system suitability criteria.* Document all analytical activities in laboratory notebooks, LIMS, and controlled forms in accordance with GDP and regulatory expectations.* Conduct investigations into atypical results, instrument issues, or method deviations, including root‐cause analysis and corrective actions.* Support method transfers, verifications, and validations by executing protocols and generating high‐quality analytical data.* Maintain laboratory readiness by ensuring proper reagent labeling, instrument logbook completion, and adherence to safety and compliance requirements.* Collaborate with cross‐functional teams (QA, Manufacturing, R&D) to support testing priorities and resolve technical issues.**EDUCATION/EXPERIENCE**The successful candidate must meet one of the following education/experience combinations:* Bachelor's degree in Chemistry, Biology, Microbiology, or another related scientific discipline with relevant laboratory coursework.* Minimum 2 years of laboratory experience, preferably in a GMP-regulated environment.* Hands-on experience with wet chemistry, balances, dissolution, FTIR, Karl Fischer Moisture (KFM), UV/Vis, titrations, viscosity, particle size distribution (PSD), pH, and conductivity testing.**job competencies*** Strong understanding of laboratory safety practices and proper PPE usage.* Working knowledge of cGMP requirements and Good Documentation Practices (GDP).* Knowledge of USP and EP compendial testing requirements.* Ability to work independently with minimal supervision and minimal laboratory errors.* Proficiency with analytical techniques including HPLC, FTIR, UV-Vis, Karl Fischer, dissolution, wet chemistry, pH testing, reagent preparation, and volumetric solutions.**job conditions**The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If any accommodations are needed, requests should be made to our Human Resources department.* ***Physical Demands****:* + Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected. + Long periods of standing and walking can be expected in this position. + This position may require long periods of sitting, typing, computer entry or looking at a computer.* ***Work Environment****:* + Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes. + Potential limited exposure to hazardous chemicals. + Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.