Biotech QA on the Floor – GMP Manufacturing Support

Bayside Solutions

Salt Lake City (UT)

Presencial

USD 70.000 - 100.000

Jornada completa

Hace 2 días
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Descripción de la vacante

Bayside Solutions is seeking a Quality Assurance Specialist to support GMP operations with strong floor-based QA involvement in Salt Lake City. The role focuses on ensuring the highest quality standards across manufacturing and warehouse areas, reviewing batch records, test data, and logs to drive right-first-time execution.

Qualified candidates have 4+ years in biotech manufacturing or QA, familiarity with large molecule drug substance production, and solid knowledge of GMP standards.

Formación

  • 4+ years in Biotech Manufacturing/QA/MSAT in GMP, regulated facilities.
  • Familiarity with large molecule drug substance manufacturing.
  • Knowledge of USP/Ph. Eur./FDA/ISO/GMP standards and guidance.
  • Experience working in GMP-regulated environments is required.
  • Strong verbal and written communication, attention to detail.
  • Proven ability to execute with accuracy and proactive approach.
  • Familiar with MasterControl and electronic batch records.

Responsabilidades

  • Execute QA on the Floor program – 50% of the time.
  • Conduct manufacturing and warehouse walkthroughs to ensure quality.
  • Provide quality support to manufacturing operations.
  • Review batch records, test data, and logs for compliance.
  • Disposition materials and escalate quality issues when needed.
  • Collaborate with manufacturing floor teams on quality matters.
  • Perform other duties as assigned.

Conocimientos

QA on the Floor
Manufacturing walkthroughs
Quality assurance
MSAT
GMP knowledge
Documentation review

Educación

BS in a scientific discipline

Herramientas

MasterControl
Electronic Batch Records

Descripción del empleo

Bayside Solutions is seeking a Quality Assurance Specialist to support GMP operations with strong floor-based QA involvement in Salt Lake City. The role focuses on ensuring the highest quality standards across manufacturing and warehouse areas, reviewing batch records, test data, and logs to drive right-first-time execution.

Qualified candidates have 4+ years in biotech manufacturing or QA, familiarity with large molecule drug substance production, and solid knowledge of GMP standards.

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