QA Specialist – Finishing Ops (cGMP Pharma Impact)

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); Presencial; USD 65 000 - 90 000; Tempo integral

Resumo da oferta

Grand River Aseptic Manufacturing (GRAM) is seeking a QA Specialist I in Finishing Operations to support quality systems for parenteral drug manufacturing and testing. You will oversee terminal sterilization, visual inspection, labeling and packaging activities and release materials as part of the QA process.

The role requires 1–2 years of related experience, knowledge of QA in pharma, and proficiency with Word, Excel and Outlook.

Qualificações

• 1–2 years related work experience.
• GMP/pharma QA knowledge.
• Proficient with Word, Excel and Outlook.
• Equivalent GMP experience may replace the degree.

Responsabilidades

• Verify compliance with terminal sterilization, visual inspection, labeling and packaging operations documentation during operations.
• Review executed batch records and other controlled documents.
• Perform clearances and start-up activities for Finishing Operations and related equipment.
• Perform QA review and approval of stability and finished products testing certificates of analysis.
• Perform QA review and material release for incoming materials.
• Adhere to cGMPs and SOPs and support quality investigations (NCRs, LIRs).

Conhecimentos

QA principles

GMP knowledge

cGMP

Microsoft Word

Microsoft Excel

Microsoft Outlook

Formação académica

Bachelor's degree in Life Sciences

Ferramentas

Microsoft Word

Microsoft Excel

Microsoft Outlook

Descrição da oferta de emprego

Grand River Aseptic Manufacturing (GRAM) is seeking a QA Specialist I in Finishing Operations to support quality systems for parenteral drug manufacturing and testing. You will oversee terminal sterilization, visual inspection, labeling and packaging activities and release materials as part of the QA process.

The role requires 1–2 years of related experience, knowledge of QA in pharma, and proficiency with Word, Excel and Outlook.