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    Gmp Operations Documentation Specialist

    Porton Pharma Solutions Ltd.
    0-4 years
    Not Disclosed
    East Brunswick
    10 May 17, 2024
    Job Description
    Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: GMP Operations Documentation Specialist (Entry Level)

    Company: Porton Pharma Solutions Ltd.

    Location: South Plainfield and Cranbury, New Jersey, USA

    Job Type: Full-time

    Schedule: 8-hour shift

    Relocation: Required to South Plainfield and Cranbury, New Jersey, USA before starting work

    Job Description:

    About the Company: Porton Pharma Solutions Ltd. is a leading pharmaceutical CDMO company that provides global pharmaceutical companies with innovative, reliable, and end-to-end process R&D and manufacturing services across small molecule APIs, dosage forms, and biologics.

    Responsibilities:

    • Support management and maintenance of the GMP operations SOP and Document Control system.
    • Prepare, review, and execute GMP documents.
    • Organize and maintain equipment logbooks.
    • Track preventive maintenance and calibrations/qualifications to ensure all GMP equipment and instruments are up-to-date.
    • Support compliance projects, such as management of quality issues, CAPA projects, or other cross-functional initiatives.
    • Help prepare for and participate in GMP audits as needed.
    • Track the periodic review status of production SOPs to ensure they remain current.
    • Research production/processing equipment or fixtures for purchase and gather data relating to their ability to meet organizational needs.
    • Develop, maintain, and provide training for J-Star personnel on GMP-related processes and procedures.
    • Manage GMP kilo lab and equipment reservation, check-out, clean-out, and check-in processes.

    Qualifications:

    • BA/BS degree or equivalent required.
    • 0-4 years of experience in a GMP-regulated pharmaceutical industry facility preferred.
    • Extensive knowledge of USP, ICH, FDA, 21 CFR, and other guidance documents.
    • Proven track record of setting and meeting aggressive targets and timely execution of objectives.
    • Excellent written, verbal, and communication skills.
    • Ability to prioritize and manage numerous projects simultaneously.
    • Ability to interact effectively and appropriately with diverse population sets.
    • Ability to communicate candidly, clearly, and timely.
    • Experience in working on, positively contributing to, and leading teams.
    • Proficient in Microsoft Office and other job-related software and applications.
    • Ability to perform the physical requirements of the position, including frequent walking, standing, stooping, crouching, bending, and reaching above and below shoulder height. This job requires twisting and turning of the body and the use of both hands.

    Reporting Relationship:

    • Reports to Associate Director or Director of GMP Operations

    Work Location:

    • In person at South Plainfield and Cranbury, New Jersey, USA

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