Biopharma QA Shop Floor Specialist — 24/7 cGMP Release

Bristol Myers Squibb; Summit (NJ); Sur place; USD 70 000 - 110 000; Plein temps

Résumé du poste

Scorpion Therapeutics is seeking a QA Shop Floor Specialist to provide 24/7 quality oversight across manufacturing, QC labs, label, and warehouse operations at a biopharmaceutical site.

The role requires applying cGMP standards, reviewing batch records, and acting as Authorized Person for release activities. You will support remediation, walk the floor, and collaborate with cross-functional teams across day and night shifts on-site.

Qualifications

• Bachelor's in STEM or equivalent experience.
• 2+ years of cGMP experience, including 1+ year in manufacturing.
• Knowledge of FDA/EMA regulations in biopharma.

Responsabilités

• Conduct routine on-the-floor quality checks.
• Interpret and triage unexpected events.
• Review batch records.
• Verify deviations, and act as Authorized Person for release activities per GMP standards.
• Engage in area walkthroughs.
• Identify quality issues.
• Support remediation plans.
• Promote a quality-centric culture.
• Collaborate with cross-functional teams and participate in shift meetings.

Connaissances

Decision-making

Problem-solving

GxP experience

Power Automate

Tableau

Formation

Bachelor's in STEM

Outils

MES

SAP

Power Automate

Tableau

Description du poste

Scorpion Therapeutics is seeking a QA Shop Floor Specialist to provide 24/7 quality oversight across manufacturing, QC labs, label, and warehouse operations at a biopharmaceutical site.

The role requires applying cGMP standards, reviewing batch records, and acting as Authorized Person for release activities. You will support remediation, walk the floor, and collaborate with cross-functional teams across day and night shifts on-site.