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Quality Assurance Associate

Company: Alphazyme Llc
Location: Jupiter
Posted on: January 12, 2022

Job Description:

The Quality Assurance Associate is responsible to support the authoring, reviewing, approving, development, implementation, and maintenance of Quality System documents, records, and resource materials. Alphazyme is focused on continuous improvement of its processes to maximize efficiency and minimize waste streams.As a member of the Quality Assurance department, the Quality Assurance Associate plays an integral role in identifying opportunities for such improvements.Key attributes for this role include strong attention to detail, a process-orientation, self-motivation, adaptability, and the ability to independently solve problems in a fast-paced environment.
Our Quality Management System allows Alphazyme to reliably manufacture enzymes consumed by industrial partners in important and large applied markets.Your work will support the Companys mission to be the partner of choice for firms who leverage the power of genomics to address some of the most complex challenges facing humanity today.

  • Supports the development, implementation, and maintenance of the Quality Management System
  • Supports operations on incoming inspections including maintenance of purchasing spreadsheet and inventory management of reagents and materials
  • Maintains approved supplier list and associated documentation for incoming materials, monitors supplier information, and conducts corrective action activities with purchasing for supplier related issues
  • Performs Quality Assurance timely reviews for documentation to ensure conformance and compliance with internal and regulatory requirements
  • Aids Quality Engineering with maintenance and review of documentation related to equipment calibration, PM, IQ, OQ, PQ, logbooks, repair, and cleaning activities
  • Aids Quality Management in Quality Events such as Non-Conformances, CAPAs, Deviations, OOSs, and Customer Complaints including entering Events into the eQMS, maintenance of related documentation, QA reviews, and communication with key stake holders on timely completion of related tasks
  • Assists in metrics tracking related to the Quality System for Management Reviews
  • Participates in Document Control activities including setup, documentation system, tagging, and training matrices
  • Participates in regulatory, internal, customer audits, and Management Reviews
  • Supports the authoring, reviewing and/or approving of SOPs, work instructions, forms, and controlled logbooks
  • Assists department personnel with editing and releasing controlled procedures and documents
  • Assures ongoing compliance with quality and industry regulatory standards and requirements
  • Recognizes opportunities for improvement, recommends and makes solutions actionable
  • Additional duties as assignedEducation / Experience / Skills
    • BA/BS or equivalent experience in document control and/or combination of experience and training.
    • Minimum 2+ Years of experience in a Pharmaceutical/Biotech or medical device environment
    • Experience in ISO/FDA Quality System Regulation environment, medical device preferred
    • Excellent written and verbal communication skills
    • Initiative and organizational skills
    • Proficient with MS Office applications
    • Practical working knowledge of electronic documentation systems, data retrieval, and electronic file formats
    • Ambitious, eager to learn and aptitude for technology
    • Experience working with an eQMS system considered a plusby Jobble

Keywords: Alphazyme Llc, Jupiter , Quality Assurance Associate, Other , Jupiter, Florida

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