Quality Control Specialist

Location: Vista, CA
Department: Quality Affairs

Description

Job Purpose:

As directed, the Quality Control Specialist is responsible for partnering with operations and product development teams to ensure product meet specifications. This position actively engages in safety testing, plastic testing, formula testing, and stability testing. This role will also work to make sure complaints are documented within our quality system, investigated, and results fed back into our risk analysis process. The incumbent will participate in sustaining engineering and process improvement initiatives as assigned. This position assists in document and change control, non-conformance, and CAPA processing.

Essential Functions:

  • Support product release and change activities in support of new and existing products.

  • Coordinate, review and manage document/procedure change work flow. Review other documentation for accuracy.

  • Conduct a final review and closure of both adverse and non-adverse event complaints from the field, escalating matters if necessary

  • Update, review and manage SOP documentation work flow.

  • Maintain the master documentation files and employee training records.

  • Maintain electronic QMS

  • Train employees on all applicable document changes.

  • Assist in the administration of the Product Complaint and CAPA systems

  • Review of required batch release testing

  • Approval/rejection of manufacturing batches from contract manufacturing partners

  • Supplier documentation management

  • Assist in the preparation of NCRs and return to vendors

  • Assist in preparing Quarantine Release documents

  • Oversight over product acceptance of Incoming materials and in process materials

  • Other duties as assigned by management

Skills/Qualifications:

  • Bachelor’s degree

  • Minimum 2 years of experience

  • Familiar with Document Release and Change Control Process. 

  • Experience in FDA and ISO regulated environments.

  • Communicate effectively, both orally and written.

  • Demonstrate ability to work independently or in a team to deliver professional work products in a timely manner.

  • Effective problem-solving skills





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