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Sr. Quality Specialist, Material Management

Karwell Technologies

  • Boston, MA
  • 30+ days ago

    Highlights

    Provides QA support in the management of SCARs assisting in determining impact to incoming raw materials and consumables as well as supporting vendor investigations. 5 years of relevant industry experience such as materials management, supply chain, quality assurance and/or manufacturing in biotechnology/regulated pharmaceutical environment.

    Numbers & Facts

    LocationBoston, MA

    Description

    Responsibilities:
    • Provides QA support overseeing the management of incoming raw materials and consumables for internal manufactured products.
    • Reviews GMP documentation for incoming raw materials and consumables for internal manufactured products.
    • Performs final review of executed GMP documentation for the management of materials and determines acceptability by using standard operating procedures.
    • Ensures presence and acceptability of all required documentation prior to the release of raw materials and consumables.
    • Supports the day-to-day management of incoming raw materials and consumables release process.
    • Provides QA support in the management of SCARs assisting in determining impact to incoming raw materials and consumables as well as supporting vendor investigations.
    • Maintains and archive files such that documents are readily available and easily retrievable.
    • Assists department with weekly/monthly/quarterly Quality System data review metrics and reporting pertaining to materials management.
    • Communicates proactively with internal and external partners as well as with management.
    • Escalates critical and major findings to Quality management.
    Requirements:
    • Bachelor's degree in a scientific or allied health field.
    • 5 years of relevant industry experience such as materials management, supply chain, quality assurance and/or manufacturing in biotechnology/regulated pharmaceutical environment.
    • Knowledge of cGMP's in a pharmaceutical setting.
    • Ability to collaborate effectively within a team.
    • Ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects.
    • Strong attention to detail.
    • Effective communication skills, both verbal and written.
    • Demonstrated success by independently leading cross-functional teams.
    Must Have Experience with the following:
    • Oversee Raw Material Inventory Management, Segregation, Storage, and Cycle Count.
    • Responsible for review and approve raw material receiving packets. Manage the raw material status in ERP system.
    • Approve new material onboarding, qualification protocols, and material qualification reports for VCGT programs.
    • Responsible for Vendor Change Notification, Supply Corrective Action Request, Raw Material related deviations, and change controls.
    • Provides QA support in the management of SCARs, Change Controls, Vendor Change Notifications, Deviation Investigations.
    • Past experience working in established biopharma companies with commercial QA Operation experience.

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