Quality Assurance Supervisor

2 weeks ago


Lebanon, Pennsylvania, United States SCHOTT Pharma Full time

Quality Assurance Supervisor

Company Overview:

SCHOTT Pharma USA has been a leader in providing innovative solutions and services to the global pharmaceutical and biotechnology sectors for over a century. Our extensive and scientifically validated product range includes vials, syringes, cartridges, and Fast Track Kits, ensuring the safe storage and administration of injectable medications worldwide.

ATTRACTIVE SKILLS/EXPERIENCES:

  • Bachelor's Degree in Chemistry, Biology, Engineering, or a related discipline
  • Minimum of 5 years in a leadership capacity, ideally within a Quality Department or Team
  • At least 3 years of experience in product/process investigations, validations, and instrument qualifications
  • Strong understanding of cGMP and ISO Standards (ISO9001; 14001; 15378)
  • Proficient in MS Office applications, SAP, and electronic Quality Management Systems
  • Experience in the pharmaceutical or glass forming industry is preferred
  • Excellent communication skills (both written and verbal), with the ability to read and speak English
  • Willingness and ability to thrive in a fast-paced, matrix-structured environment

SUMMARY / RESPONSIBILITIES:

The Quality Assurance Supervisor will lead the Quality Department and act as the deputy to the Site Quality Manager. This role involves supporting daily operations and contributing to the strategic planning of the department. The supervisor will assist all quality teams by implementing policies, procedures, and accountability measures to ensure compliance with regulatory standards and performance metrics.

Key responsibilities include:

  • Leading, coaching, and inspiring team members to achieve departmental goals and site objectives
  • Developing employee skills through training and performance evaluations, as well as participating in the hiring process
  • Overseeing the validation and re-validation of sterilization processes, including new cycle development and annual reporting
  • Managing the validation process and driving process improvements across the site and laboratories
  • Establishing processes for monitoring and trending relevant quality KPIs, including environmental monitoring, raw materials, and finished product testing
  • Conducting site-based risk assessments
  • Supporting the development and revision of Quality Assurance programs, policies, processes, and controls, including CAPA and Change Control
  • Reviewing and analyzing quality discrepancies related to products, and developing corrective actions
  • Coordinating training activities and projects within the department
  • Managing document control processes, including the release, archiving, tracking, and reporting of controlled documents
  • Leading the implementation of compliance improvements and ensuring adherence to data integrity requirements
  • Overseeing the internal audit function to maintain compliance with the Quality Management System (QMS)
  • Managing assigned CAPAs by conducting root cause investigations and implementing timely corrective actions
  • Ensuring compliance with ISO certifications and cGMP, along with adherence to company policies and safety guidelines
  • Performing additional duties as assigned


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