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    Lead Quality Control Analyst

    Piramal Pharma
    3+ years
    Not Disclosed
    Bethlehem
    10 Jan. 8, 2025
    Job Description
    Job Type: Full Time Education: B.S. 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: Lead Quality Control Analyst

    Location: Bethlehem, PA, United States
    Business Unit: Critical Care
    Department: Quality Control
    Travel: None

    Job Overview

    The Lead Quality Control Analyst will provide compliance and testing support to the Quality Control Laboratory and lead the Quality Control Analysts in a manufacturing site environment. This role involves ensuring adherence to quality systems, regulations, and operational procedures to maintain high-quality products and facilitate regulatory compliance.

    Key Responsibilities

    Quality Control Lab Operations

    • Help maintain all QC Lab equipment in proper operational state.
    • Perform activities to ensure compliance with quality systems, procedures, and regulatory requirements, facilitating compliance with agencies and customers.
    • Develop, implement, and maintain programs and processes to ensure high-quality products and adherence to GMP, ICH, and regulatory guidelines.
    • Assist in maintaining QC Lab documentation such as SOPs, methodology, specifications, calibration sheets, and logbooks through change control, when necessary.

    Investigation and Continuous Improvement

    • Lead or participate in focused deviation cross-functional investigations, improvement projects, and other initiatives.
    • Identify Continuous Improvement Opportunities and perform their implementation.
    • Support management strategies related to compliance and data integrity.
    • Conduct in-process sample testing, record reviews, and approval for release when required.
    • Support quality systems, including laboratory investigations, deviation investigations, analyst training, and CAPA.

    Product Development and Documentation

    • Participate in product development support, including methodology transfers, stability programs, project management, excel validations, and special studies for regulatory filings.
    • Prepare protocols, reports, validation logs, and other documentation as needed.
    • Ensure timely testing by managing the whiteboard for analysts' schedules to meet targeted turnaround times (TAT).

    Team Management and Support

    • Manage activities related to the recruitment, training, scheduling, and performance management of direct reports.
    • Maintain and collect data on internal Key Performance Indicators (KPIs) for QC employee efficiency.
    • Assist and back-up the QC Manager in reviewing, approving, and releasing product, raw materials, and test results.

    Essential Qualifications and Experience

    • Education: B.S. in Chemistry or a related scientific discipline is required.

    • Experience:

      • Minimum 3+ years’ experience working in a pharmaceutical QC manufacturing laboratory, especially with Gas Chromatography (GC).
      • Experience in analytical method development, transfer, verification, and validation.
      • Familiarity with laboratory instrumentation such as GC, GC-MS, ICP-MS, IR, Karl Fischer, pH, UV-VIS, and refractive index.
      • Experience with laboratory instrument qualification, preventive maintenance, and calibration.
      • Proficiency with computer office tools (Word, Excel, LIMS, Outlook, scientific databases, etc.).
      • Experience in supporting FDA, EU, corporate, and other regulatory audits.
      • Knowledge of FDA regulations, ICH guidelines, and cGMP guidelines.
      • Strong documentation and technical writing skills.

    • Skills and Competencies:

      • Ability to work in a fast-paced environment and manage multiple projects with competing priorities.
      • Strong problem-solving skills and flexibility.
      • Excellent verbal and written communication skills.
      • Knowledge of pharmaceutical regulations and audit experience is a plus.

    Job Conditions

    • Perform testing on in-process materials, bulk drug substances, finished drug products, and stability samples.
    • Schedule and oversee nightshift QC Analyst testing.
    • Conduct laboratory and deviation investigations.
    • Perform calibration, preventive maintenance, and troubleshooting on analytical equipment.
    • Execute analytical method validation/verification in a cGMP environment.
    • Manage ordering through SAP inventory management system.
    • Work on special projects assigned by QC management.

    About Us

    Piramal Critical Care (PCC) is committed to providing high-quality critical care solutions globally, serving the healthcare industry with a focus on compliance, innovation, and operational excellence. Our efforts are aligned with regulatory standards to ensure the safety and quality of our products.

    Equal Employment Opportunity

    Piramal Group is an Equal Employment Opportunity employer, committed to fostering a diverse and inclusive workplace and ensuring equal opportunity for all applicants, based on merit and qualifications.

    Join Piramal Critical Care as a Lead Quality Control Analyst and play a crucial role in ensuring the highest standards of quality and regulatory compliance in pharmaceutical manufacturing.

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