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    • QA Associate- Supplier Qualification - Hunt Valley - Pharmaceutics International Inc

    Pharmaceutics International Inc
    Pharmaceutics International Inc Hunt Valley

    1 month ago

    Default job background
    Full time
    Description

    Job Title: Quality Specialist, Supplier Quality

    **Job Summary:**

    The Quality Specialist, Supplier Quality is responsible for supporting a Supplier Quality system in compliance with 21 CFR part 210/211 regulations. This position reports to the Director of Supplier Quality and plays a crucial role in ensuring continued compliance to Pii's Supplier Quality Management program.

    **Responsibilities:**

    • Process and track supplier/material onboarding requests, ensuring timely completion and compliance.
    • Obtain all necessary documentation/agreements required to qualify suppliers/materials, verifying their accuracy and completeness.
    • Determine proper supplier classification based on provided information, categorizing them accordingly.
    • Track and process Supplier Notifications of Change (SNCs), assessing potential impacts on our quality management program.
    • Hold meetings with Subject Matter Experts (SMEs) to evaluate the effects of supplier changes, making informed decisions when needed.
    • Initiate and process Change Controls as required, maintaining a record of revisions and updates.
    • Generate material receipt reports and Quality Event reports to assess supplier performance, identifying areas for improvement.
    • Conduct ongoing supplier evaluations, monitoring their adherence to our quality standards.
    • Issue Supplier CAPA requests and follow up on closures as necessary, ensuring resolution and prevention of future issues.
    • Coordinate, prepare for, and assist with Supplier Audits, facilitating open communication and cooperation between teams.
    • Create or edit Supplier Quality Standard Operating Procedures (SOPs), forms, and other materials in Master Control as needed, maintaining accuracy and consistency.
    • Proactively identify process improvements and communicate suggestions to the Director, contributing to continuous quality enhancement.
    • Perform general office administrative tasks (scanning, copying, sorting, filing, etc.), providing support to the team.
    • Assist in implementing an electronic Supplier Quality Management system (e.g., Master Control), streamlining processes and increasing efficiency.
    • Develop Purchasing/Material Specifications as required, ensuring clarity and relevance.
    • Perform any additional Quality Assurance Tasks assigned by the Director, adapting to changing needs and priorities.

    **Requirements:**

    • Bachelor's/Associate's degree in a scientific discipline with at least two years of experience working in the Biotech or Pharmaceutical industry under GMP conditions, preferably in Quality Assurance.
    • Effective English oral and written communication skills, enabling clear interaction with colleagues, vendors, and stakeholders.
    • Proficiency in MS Office computer applications: Outlook, Word, Excel, etc., using software efficiently and effectively.
    • Ability to work independently, collaboratively within a team, and provide assistance during projects and audits, demonstrating flexibility and adaptability.
    • Capacity to gather relevant data, make informed decisions, and form teams for collective discussions, promoting a culture of open communication.
    • Capability to thrive in a fast-paced environment, rapidly adjusting priorities and multitasking while maintaining a professional demeanor.
    • Possibility of travel may be required – approximately up to 10%.

    **Qualifications:**

    Previous Supplier Quality experience is preferred but not mandatory. Previous experience in Master Control or another Electronic QMS system is also advantageous.

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