Manager, QA Floor OperationsPenn Life Sciences • Fort Washington, Maryland, United States
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Manager, QA Floor Operations
Penn Life Sciences
- Fort Washington, Maryland, United States
- Fort Washington, Maryland, United States
Über
* 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 * Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed * Paid Time Off * 10 paid company holidays * Comprehensive medical, dental, vision, and life insurance coverage * Professional development reimbursement * Career growth opportunities
Schedule
* Full-time, on-site (7:00 am - 4:00 pm)
Sprachkenntnisse
- English
Hinweis für Nutzer
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