R-235089 Quality Assurance Specialist - Manufacturing Support

Amgen

US
Base: 104,287.35usd - 141,094.65usd; bonus/equity:...
**
Cgmp compliance
Good documentation practices
Deviation investigation
** Amgen is seeking a Quality Assurance Specialist to support its manufacturing operations, ensuring compliance with quality standards and regulations in the biotech industry. The role involves direct collaboration with manufacturing staff, oversight of quality processes, and participation in audits and inspections. **

Job Summary

  • Serve as Quality Assurance Specialist responsible for Plant Quality Assurance (PQA) supporting bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.
  • Provide coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems.
  • Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.

Matching Summary

Match Score: 75

** Amgen is seeking a Quality Assurance Specialist to support its manufacturing operations, ensuring compliance with quality standards and regulations in the biotech industry. The role involves direct collaboration with manufacturing staff, oversight of quality processes, and participation in audits and inspections. **

Salary

Base: 104,287.35USD - 141,094.65USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • cGMP compliance
  • Good Documentation Practices
  • deviation investigation
  • change control assessment
  • regulatory compliance

Nice-to-have

  • collaborative partnerships
  • continuous improvement
  • patient-focused mission
  • biotech manufacturing environment

Key Requirements

  • High school diploma/GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience
  • Associate’s degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience
  • Bachelor’s degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience
  • Master’s degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience
  • Doctorate degree

Work Rights

Not specified

Tailored Resume

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