QA Specialist II

QA Specialist II

02 Sep 2021
Maine, Scarborough, 04074 Scarborough USA

QA Specialist II

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QA Specialist II
The position of Quality Assurance Specialist II is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will under minimal direction, the scope of this position is to perform a wide variety of activities to support the Quality Management System.

  • Assures the quality of manufactured products and processes per standard operating processes (SOP'S) and GMP (Good Manufacturing Practices).
  • Conduct spot-check inspections/audits of production operations
  • Participate in the internal audit program
  • Write, review and approve Standard Operating Procedures (SOPs) as necessary
  • Assist with and may write validations/test protocols as necessary
  • Assist in testing of complaint samples and stability samples and reports results out of acceptance limits
  • Initiate and author Deviations and Quality Incidents (QI)
  • May organize the long term stability program and be responsible for administering the sample retention program.
  • May administer the Quality Records program and assist and act as backup to the Document Control Specialist II (with administrator rights in site electronic documentation system).
  • Train new and current Quality Assurance Technician and Specialists as needed
  • Change Control Management:
    • Change Management Documentation
    • Compile and maintain quality system records associated with design change projects, including project definitions, first-lot-to-stock, product qualification records, etc.
    • Ensure records for design change projects are complete and align with SOPs.
    • Manage organization, storage, and archival of documentation and records associated with design changes and labeling.
  • Labeling Process Administration:
    • Provide proofreading of product labeling prior to team review and approval.
    • Initiate, execute and implement label changes in coordination with interdepartmental and external stakeholders.
  • Change Control Execution:
    • Assist with implementation of product changes, in conjunction with project leads.
    • Manage assigned Design Change projects (Typically associated with product labeling)

  • Bachelor's Degree in Chemistry, Biology, Life Science, or other related technical field in a scientific or technical area or the equivalent combination of education and experience
  • 3+ years prior experience in a Quality Assurance role or similar support role in the medical device industry.
  • Ability to follow procedures and accurately document results
  • Knowledge of site software for inventory management, Document Control and Quality incident tracking
  • Ability to understand manufacturing processes of Company products and ability to recognize deviations from approved documented procedures

VOLT is an equal opportunity employer

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