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    Qc Lab Compliance Manager

    Enzene Biosciences Ltd.
    5-7 years
    Not Disclosed
    Hopewell
    10 Jan. 2, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: QC Lab Compliance Manager
    Company: Enzene
    Location: Hopewell, New Jersey, United States

    About Enzene
    Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a significant operational presence in India. As a subsidiary of Enzene Biosciences, a leading biotechnology company, our mission is to provide high-quality biologics manufacturing services to our clients, contributing to the advancement of the pharmaceutical industry.

    Website: www.enzene.com

    Position Overview
    The QC Lab Compliance Manager is responsible for ensuring that laboratory operations meet regulatory standards and produce high-quality results. This role will primarily focus on Stability and Sample Receipt programs, ensuring compliance across all laboratory activities and operations.

    Key Responsibilities

    • Quality Control Oversight: Manage laboratory processes and workflows, ensuring they adhere to quality and compliance standards. Oversee the development and management of Stability and Sample Receipt programs.
    • Equipment Management: Review equipment logbooks, audit trails, and perform regular checks on preventative maintenance and calibration of laboratory equipment.
    • Handle Non-Conformities: Investigate and resolve compliance issues such as Out of Specification (OOS) results and deviations. Initiate change controls and implement Corrective and Preventive Actions (CAPA) as necessary.
    • Conduct Audits and Inspections: Perform regular audits and inspections to verify that laboratory practices and documentation meet regulatory standards.
    • Technology Transfer and Method Validation: Lead protocol and report writing efforts, provide training, and support method execution in collaboration with Lab Managers.
    • Training: Maintain and review training records, identify staff training needs, and create programs to enhance team competency. Responsible for maintaining the department's training curriculum within the Quality Management System (QMS).
    • Team Leadership: Lead, mentor, and train a team of lab compliance officers and technicians.
    • Compliance: Stay up-to-date with industry regulations to ensure the lab operates in full compliance with all applicable laws and standards.
    • Data Analysis and Reporting: Analyze laboratory data and compliance reports to identify trends or areas for improvement. Present findings at department and global meetings.

    Qualifications

    • Education: Bachelor’s Degree in Chemistry, Biochemistry, Biotechnology, or a related field.
    • Experience: 5-7 years of lab experience, focusing on analytical method development, validation, and transfer within the biopharmaceutical industry. At least 1-3 years of experience in compliance investigations and audits.
    • Skills: Proficient in analytical methods such as HPLC, UPLC, Gas Chromatography, Mass Spectrometry, ELISA, and others. Experience with LIMS, Veeva, TrackWise, and Master Control systems is required.

    Why Join Enzene?
    At Enzene, we cultivate a collaborative and innovative environment where science and business come together. We are dedicated to advancing biosimilar manufacturing and continuously improving processes to enhance patient outcomes. Joining Enzene means becoming part of a company that values integrity, innovation, and collaboration in the pursuit of scientific excellence.

    Equal Opportunity Employer
    Enzene is an equal opportunity employer, committed to fostering a diverse and inclusive work environment where all employees can thrive.

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