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    Senior Qc Analyst

    Piramal Pharma
    5+ years
    Not Disclosed
    Sellersville
    10 Jan. 8, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior QC Analyst

    Location: Sellersville, PA, United States
    Department: Quality Control
    Business: Piramal Pharma Solutions
    Travel: N/A

    Job Overview

    The Senior QC Analyst performs analytical chemistry testing on raw materials, finished products, or stability samples, following approved Standard Operating Procedures (SOPs) and valid testing methods. This role involves working in a safety-sensitive environment, with a focus on accurate data collection and compliance with regulatory requirements.

    Key Responsibilities

    Testing and Analysis

    • Perform chemical and physical testing analysis on raw materials, finished products, stability, or request samples.
    • Document and submit all raw data and results in the Laboratory Information Management System (LIMS).
    • Prepare reagents for chemical analysis and participate in peer reviews.
    • Conduct testing in compliance with compendial (USP/EU) requirements and ensure adherence to FDA 21 CFR standards.
    • Perform independent HPLC testing such as assay, blend uniformity, impurity analysis, dissolution, and content uniformity.
    • Handle various laboratory equipment, including balance, FTIR, dissolution, UV-VIS, Karl Fischer, pH meters, wet chemistry techniques, GC, PSD, Malvern, XRD, etc.

    Documentation and Reporting

    • Ensure all documentation follows good documentation practices (GDP), with minimal errors.
    • Prepare and maintain technical documentation, including protocols, reports, specifications, and laboratory investigations.
    • Responsible for sample preparation, reagent preparation, and data processing from start to finish independently.

    Safety and Compliance

    • Ensure compliance with cGMP guidelines and laboratory safety practices.
    • Maintain a zero-tolerance approach to safety violations and ensure proper use of Personal Protective Equipment (PPE).

    Training and Mentoring

    • Train and mentor other analysts as needed.
    • Coordinate communication with outside vendors and clients for laboratory matters.

    Qualifications

    Education

    • Bachelor's degree in Chemistry, Biology, Microbiology, or a related science with relevant laboratory coursework.

    Experience

    • Minimum of 5 years of laboratory experience, preferably in a GMP environment.
    • Proficiency in wet chemistry testing, including balance, dissolution, FTIR, Karl Fischer, UV/Vis, titrations, viscosity, PSD, pH, and conductivity testing.
    • Experience with HPLC testing (assay, blend uniformity, impurity analysis, dissolution, content uniformity).

    Skills

    • Strong understanding of laboratory safety practices and PPE.
    • In-depth knowledge of cGMP, compendial testing (USP/EU), and international compendia such as EP.
    • Proficient with computer software, including MS Word, Excel, and PowerPoint.
    • Excellent organizational, multitasking, and time management skills.
    • Excellent interpersonal, communication, and problem-solving skills.
    • Ability to work independently and handle multiple projects with changing priorities.

    About Us

    Piramal Pharma Solutions (PPS) is a global leader in contract development and manufacturing services, providing integrated solutions across the pharmaceutical lifecycle. We deliver high-quality services from drug discovery through to commercial manufacturing, specializing in APIs, finished drug products, biologics, and other advanced therapies.

    Equal Employment Opportunity

    Piramal Group is an Equal Employment Opportunity employer. We do not discriminate based on race, ethnicity, religion, color, national origin, gender, sexual orientation, age, disability, or any other legally protected characteristic.

    Apply Now

    If you’re an experienced QC Analyst with a strong background in laboratory testing, compliance, and safety, apply to join our team as a Senior QC Analyst at Piramal Pharma Solutions today!

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