Senior QA Floor Leader – Sterile Injectable Ops

Penn Life Sciences; Langhorne (Bucks County); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Annual performance bonus eligibility

Annual merit-based pay increases

Job summary

Penn Life Sciences is seeking a Manager, QA Floor Operations to provide strategic and hands-on QA leadership on the sterile manufacturing floor. The role ensures compliant aseptic processing, accurate documentation, and timely quality decisions, acting as the key liaison among Manufacturing, Quality Control, Engineering, and Quality leadership.

Responsibilities include leading on-floor QA activities for aseptic filling and packaging, approving line and equipment changes, reviewing batch records,

Qualifications

• 7–10 years of QA experience in a cGMP-regulated sterile injectable pharma environment.
• On-floor QA oversight of aseptic manufacturing operations.
• Experience leading QA floor teams in a sterile setting.
• Experience supporting FDA inspections preferred.

Responsibilities

• Lead daily QA Operations for sterile injectable manufacturing and packaging.
• Provide real-time QA presence on the manufacturing floor.
• Review line clearances, room clearances, and equipment releases.
• Review batch records and GMP documentation for accuracy and compliance.
• Exercise quality decision-making during manufacturing, including deviations and CAPA.
• Oversee on-floor inspections and environmental controls.
• Initiate and approve deviation investigations and root cause analyses.

Skills

QA Leadership

On-floor Oversight

GMP Compliance

Regulatory Inspections

CAPA Investigations

Document Control

Data Integrity

Leadership

eQMS

Microsoft Office

Education

Bachelor's degree in Chemistry/Pharmaceutical Sciences/Engineering

Tools

Microsoft Office

eQMS

Job description

Penn Life Sciences is seeking a Manager, QA Floor Operations to provide strategic and hands-on QA leadership on the sterile manufacturing floor. The role ensures compliant aseptic processing, accurate documentation, and timely quality decisions, acting as the key liaison among Manufacturing, Quality Control, Engineering, and Quality leadership.

Responsibilities include leading on-floor QA activities for aseptic filling and packaging, approving line and equipment changes, reviewing batch records,