Pharma QA Supervisor - Onsite, Process & Compliance

Catalent; Philadelphia (Philadelphia County); Presencial; USD 85.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

PTO and holidays

401K match

Health, dental and vision benefits

Tuition reimbursement

WellHub program

Discounts via Perkspot

Descripción de la vacante

Catalent's Philadelphia facility serves as a global Center of Excellence for GMP secondary packaging and clinical labeling. The QA Supervisor will oversee incoming, distribution, and destruction QA activities on-site in Philadelphia, ensuring product quality and regulatory compliance.

The role partners with Supply Chain and Operations to drive process improvements, investigations, and metrics tracking while enforcing FDA cGMPs and Catalent policies in a fast-paced manufacturing environment.

Formación

• HS Diploma/GED and 5+ years of Production QA experience required.
• College degree preferred (BA, BS).
• Proven track record of monitoring/auditing quality and identifying potential efficiencies in a production environment.
• Previous supervisory experience of 5 years or more preferred.
• Experience in a regulated field – pharma, food, automotive, etc.
• Experience working on continuous improvement activities in partnership with other functions (e.g. Production, Validation, etc.)
• Good Computer Skills. Knowledge of MS Office and Inventory Management system are a plus.
• Basic knowledge of Lean Six Sigma methodologies an advantage
• Good knowledge of the application of FDA cGMP’s.

Responsabilidades

• Responsible for all QA activities related to incoming, distribution and destruction and process auditing
• Assist In ensuring the quality and identity of pharmaceutical products during all aspects of the incoming, distribution, or packaging processes
• Act as the Quality partner to support the Supply Chain and Operations department
• Enforce Catalent policy and regulatory requirements
• Act as site subject matter expert for "Good Manufacturing Practices" and "Good Distribution Practices"
• Work to schedule a daily resource plan to support Supply Chain/Operations activities
• Act as lead investigator for all compliance issues regarding incoming, distribution, returns, destruction, or packaging/production
• Develop process excellence and efficiencies prior to the beginning of a project
• Track and report metrics and identify trends and predictive models
• All other duties as assigned

Conocimientos

QA supervision

Quality auditing

Regulatory compliance

Process improvement

Cross-functional collaboration

Educación

HS Diploma/GED

BA/BS preferred

Herramientas

MS Office

Inventory management system

Descripción del empleo

Catalent's Philadelphia facility serves as a global Center of Excellence for GMP secondary packaging and clinical labeling. The QA Supervisor will oversee incoming, distribution, and destruction QA activities on-site in Philadelphia, ensuring product quality and regulatory compliance.

The role partners with Supply Chain and Operations to drive process improvements, investigations, and metrics tracking while enforcing FDA cGMPs and Catalent policies in a fast-paced manufacturing environment.