Specialist QA Shop Floor

Scorpion Therapeutics; Summit (NJ); On-site; USD 70,000 - 110,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Decision-making

Problem-solving

GxP experience

Power Automate

Tableau

Education

Bachelor's in STEM

Tools

MES

SAP

Power Automate

Tableau

Job description

Role:

QA Shop Floor Specialist responsible for 24/7 quality oversight of manufacturing, QC labs, label, and warehouse operations at a biopharmaceutical site.

Objectives:

ensure compliance with cGMP, support manufacturing quality, and facilitate continuous improvement.

Responsibilities:

• conduct routine on-the-floor quality checks
• interpret and triage unexpected events
• review batch records
• verify deviations, and act as a designated 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.

Requirements:

• Bachelor's in STEM or equivalent experience
• 2+ years of cGMP experience
• including 1+ years in manufacturing
• with knowledge of FDA/EMA regulations in biopharma or cell therapy.

Skills Include:

decision-making, problem-solving, GxP systems (MES, SAP), and digital tools (Power Automate, Tableau).

Preferred:

experience with aseptic processes, quality management systems, and working in cleanroom environments.

Reporting:

to the Manager, QA Shop Floor.

Work Setup:

multiple shifts (days and nights), on-site.

High-value Specifics:

biopharma manufacturing, cGMP compliance, quality assurance in sterile and aseptic environments.