Penn Life Sciences · 1 week ago
Manager, QA Floor Operations
Langhorne, PA
Full-time
Onsite
Senior Level
$115K/yr - $130K/yr
7+ years expPenn Life Sciences is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. The Manager, QA Floor Operations provides strategic and hands-on Quality Assurance leadership with continuous oversight of sterile manufacturing and packaging operations.
BiotechnologyHealth CareLife ScienceManufacturing
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
Qualification
Required
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
Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or a related scientific discipline required
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)
Preferred
Experience supporting regulatory inspections (FDA and client audits) in a sterile facility strongly preferred
Benefits
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Professional development assistance
Referral program
Relocation assistance
Tuition reimbursement
Vision insurance
Company
Penn Life Sciences
Penn Life Sciences is a healthcare sector development and manufacture of high-quality, FDA-approved medicines for patient needs.
51-200 employees
H1B Sponsorship
Penn Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (9)
2023 (11)
2022 (23)
2021 (7)
2020 (8)
Funding
Current Stage
Growth StageCompany data provided by crunchbase