Quality Assurance Associate

1 day ago

Salt Lake, Utah, United States TCI Biotech USA Full time $23,000 - $46,000 per year

General Description:

The Quality Assurance Associate will inspect, test, review, investigate, verify, and streamline the quality assurance/quality control processes in Quality, Production, Manufacturing, Packaging and other quality-related areas, to provide quality support and coverage in Production ensuring all products and materials are meeting specifications, compliance and regulatory standards. The Quality Assurance Associate will also provide documental support in performing quality check and review on batch records and creating, revising, and training SOPs, ensuring all quality inspection are complete in a timely and compliant manner. This position will record, handle, and report any quality-related issues in Production to the Quality Assurance Supervisor.

Location: 737 E 1180 S, American Fork, UT On-site)

Schedule: Monday - Thursday 6 PM - 6 AM

Hourly: $ $23.00/hr

Responsibilities:

  • Responsible for all quality assurance/quality control activities in Production and other respective areas.
  • Enforce GMP/GDP on the floor and ensure all SOPs are being followed strictly.
  • Perform MBR/batch records review and quality inspection as outlined in the product specification and compliance.
  • Perform cleaning verification and swab testing on equipment in the production areas.
  • Ensure quality review, verification, approval, and release on incoming raw materials and components, in-process blend, and bulk and final release of finished product shipping.
  • Prepare testing and retention samples, send out samples for third-party materials and product testing. Monitor the testing and CofA status.
  • Perform in-house QC testing as assigned.
  • Oversee materials and product quarantine, QA Hold, and retention sample storage.
  • Assist Quality Assurance Supervisor in creating, reviewing, updating Standard Operation Procedures, forms and other controlled documents.
  • Coordinate and provide cGMP/cGDP and new/updated SOPs training to new hires and other departments.
  • Provide quality support to Production to ensure seamless batch record paper-flowing and documenting throughout the production manufacturing processes.
  • Ensure all daily scale check and calibration, room and equipment cleaning and sanitation, temperature and humidity monitoring and other ground inspection are recorded in the appropriate logbooks in Production & Warehouse.
  • Assist in Quality Internal Audit and other FDA, NSF, SQF regulatory and vendor audits.
  • Assist in CAPA, NC, Rework, Procedure Deviation investigations.

Required Skills:

  • Good oral and written expression, detail-oriented, interpersonal/effective communication skills
  • Be able to work independently as well as in a team setting.
  • Multi-task ability, overseeing multiple production lines, in a fast-paced working environment.
  • Performs other duties and projects as assigned by Quality Assurance Supervisor and Quality Management.
  • Keen GMP/GDP knowledge in Quality Control/Quality Assurance.
  • Bilingual (Spanish) preferred.
  • Experience with SAP systems preferred.

Experience:

  • 1+ years of Document Control Experience
  • 1+ years of cGMP/cGDP Experience in Quality Control/Quality Assurance
  • Experience in dietary supplement/nutraceutical products
  • Microsoft office, word, excel and Google Doc

Education:

  • High School diploma required
  • Associate or BS/BA College degree preferred
  • Job Type: Full-time

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