Penn Life Sciences is seeking an experienced Manager QA Floor Operations to join our team in Langhorne PA.The Manager QA Floor Operations is responsible for providing real-time Quality Assurance leadership and oversight of sterile manufacturing and packaging activities. This role serves as the primary QA authority on the manufacturing floor ensuring aseptic operations are executed in compliance with cGMP requirements approved procedures and internal quality standards. The position partners closely with Manufacturing Quality Control and Facilities to support compliant batch execution effective issue resolution and ongoing inspection readiness within a sterile injectable environment.This positions responsibilities will include but not be limited to the followingProvide continuous on-floor Quality Assurance oversight of sterile manufacturing and packaging operations including aseptic processing and critical process controls.Review and approve line clearances room and equipment release and product changeovers to ensure compliance with aseptic and procedural requirements.Review executed batch production and packaging records for accuracy completeness and compliance prior to batch disposition.Exercise real-time QA decision-making authority during manufacturing operations including assessment and escalation of deviations interventions and aseptic risks.Oversee and support deviation investigations root cause analyses and CAPA related to on-floor manufacturing activities.Support sterility assurance initiatives including environmental monitoring oversight media fills and contamination investigations.Provide leadership during internal audits and regulatory inspections including direct on-floor interaction with inspectors as required.We are looking for applicants withBachelors degree in Chemistry Pharmaceutical Sciences Biology Engineering or a related scientific discipline required.7-10 years of progressive Quality Assurance experience within a cGMP-regulated sterile injectable 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 manufacturing facility.Strong knowledge of aseptic processing sterility assurance data integrity ALCOA and cGMP regulations 21 CFR Parts 210211.What we offer 401k with company matchHealth vision and dental InsuranceChildcare expense reimbursementTuition reimbursementAnnual bonus eligibilityAnnual merit increasesPaid Time Off and Flexible HolidaysPenn Life Sciences is an affirmative actionequal opportunity employer and does not discriminate in hiring or employment on the basis of age sex race color religion national origin gender identity veteran status sexual orientation or any other protected status.We encourage you to apply if you feel that you are a match We look forward to hearing from you.