Quality Control Laboratory Supervisor

Plastikon Healthcare is looking for a Quality Control Laboratory Supervisor to support GMP laboratory activities for an aseptic filling CMO; supporting Medical Device and Pharmaceutical product platforms, including personnel management, project management, analytical method development, and validation. The position is responsible for the development, optimization, trouble-shooting and technical transfer of routine and non-routine chemical and microbial assays and formulation transfers and will support process qualification. The incumbent works independently and collectively as part of an integrated team environment with extensive interactions with Manufacturing, Maintenance, and administrative departments. The position is responsible for site nonconformance investigations and associated CAPA, risk assessment, OOS investigations, and product release/disposition.

Duties

• Supervise the quality control team, providing guidance and support to ensure effective performance.
• Develop, implement, and maintain quality assurance protocols in accordance with industry standards such as ISO 9001, ISO 13485, HACCP, and CGMP.
• Conduct regular quality audits to assess compliance with established procedures and identify areas for improvement.
• Collaborate with production teams to fabricate products that meet quality specifications while minimizing defects.
• Analyze quality data and prepare reports on findings, trends, and recommendations for continuous improvement.
• Train staff on quality control procedures and best practices to foster a culture of quality within the organization.
• Investigate customer complaints related to product quality and implement corrective actions as necessary.
• Other duties as assigned.

Qualifications

• BS/MS in science major, 7 years laboratory supervisory experience in a pharmaceutical or medical device facility, 7 years of Quality Control experience, working knowledge of laboratory safety systems and chemical safety programs. Experience in ISO standard execution.
• Proven experience in quality assurance or quality control within a manufacturing environment.
• Strong knowledge of QA/QC methodologies, including experience with HACCP, CGMP, and ISO 9001 standards.
• Familiarity with quality management systems and tools for conducting effective quality audits.
• Excellent analytical skills with the ability to interpret complex data sets related to product quality.
• Strong leadership abilities with excellent communication skills to effectively interact with cross-functional teams.
• Detail-oriented mindset with a commitment to maintaining high-quality standards.

Join our team as a Quality Control Laboratory Supervisor and play an essential role in ensuring the highest standards of product quality are met consistently.