Manager, QA Floor Operations (Sterile Injectables)

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

The Manager, QA Floor Operations provides strategic and hands-on Quality Assurance leadership with continuous, real-time oversight of sterile manufacturing and packaging operations. This role serves as the primary Quality Assurance authority on the manufacturing floor, ensuring compliant execution of aseptic processing, accurate documentation, effective quality decision-making, and sustained inspection readiness. The position leads on-floor QA Operations activities, supports timely resolution of quality issues during live manufacturing, and acts as a critical liaison between Manufacturing, Quality Control, Engineering, and Quality leadership to maintain alignment, escalation, and regulatory compliance.

Key Responsibilities

• Lead and oversee daily QA Operations activities supporting sterile injectable manufacturing and packaging, including aseptic processing, filling, lyophilization (if applicable), and visual inspection support.
• Provide continuous, real-time QA presence on the manufacturing floor to support compliant execution of batch operations, aseptic techniques, and critical process controls.
• Review and approve line clearances, room clearances, equipment release, and product changeovers in accordance with approved procedures and aseptic requirements.
• Review executed batch production records, batch packaging records, and associated GMP documentation for accuracy, completeness, and compliance prior to disposition.
• Exercise quality decision-making authority during manufacturing operations, including assessment of deviations, interventions, procedural discrepancies, and aseptic risks.
• Oversee in-process inspections and on-floor verification activities to ensure adherence to approved procedures, environmental controls, and sterile manufacturing standards.
• Initiate, review, and approve deviation investigations, root cause analyses, and CAPA related to manufacturing, aseptic processing, and on-floor activities.

What We're Looking For

Experience:

• Minimum of 7-10 years of progressive Quality Assurance experience in a cGMP-regulated sterile injectable pharmaceutical manufacturing environment.
• Demonstrated experience providing on-floor QA oversight of aseptic manufacturing operations.
• Prior experience leading or managing QA Operations or QA floor teams in a sterile environment.
• Experience supporting regulatory inspections (FDA and client audits) in a sterile facility strongly preferred.

Education:

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or a related scientific discipline required.
• A combination of education and relevant experience will be considered.

Skills & Knowledge:

• Advanced working knowledge of cGMP regulations applicable to sterile injectable manufacturing (21 CFR Parts 210/211).
• Strong understanding of aseptic processing principles, sterility assurance, environmental monitoring, and contamination control strategies.
• Demonstrated ability to provide decisive, real-time QA judgment during live manufacturing operations.
• Experience supporting deviations, investigations, CAPA, batch disposition, and inspection readiness.
• Strong understanding of data integrity principles (ALCOA+) and good documentation practices.
• Proven leadership ability in fast-paced, regulated manufacturing environments.
• Proficiency with Microsoft Office applications and electronic quality management systems (eQMS).

What We Offer

• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases