Quality Supervisor

About the role

Medisca is seeking a Quality Supervisor to lead the quality function at its Plattsburgh facility. The role ensures compliance with current Good Manufacturing Practices (cGMP) across material inspection, production, and continuous improvement activities.

Key responsibilities

• Oversee inspection and release of incoming materials and coordinate with external testing labs.
• Review, approve, and maintain Standard Operating Procedures in line with regulatory requirements.
• Supervise re‑packaging production activities and ensure adherence to cGMP.
• Lead deviation, non‑conformance (NCMR), and CAPA investigations, identifying root causes and implementing corrective actions.
• Manage environmental monitoring, equipment calibration, and maintenance programs.
• Control quarantine, rejection, rework and return‑to‑supplier processes, ensuring timely disposition.
• Support change control activities and provide feedback on quality assessment change requests.
• Generate quality KPIs, drive continuous improvement, and mentor a team of quality personnel.

Required profile

• Bachelor’s degree or higher in a scientific discipline.
• 3–5 years of experience in quality assurance or regulatory affairs within a pharmaceutical or related manufacturing environment.
• Strong knowledge of cGMP, 21 CFR Part 211, GUI‑0104, GUI‑0069, ICH guidelines, ISO 9001 and ISO 13485.

Required skills

• cGMP compliance
• 21 CFR Part 211
• GUI‑0104 and GUI‑0069
• ICH guideline implementation
• ISO 9001
• ISO 13485

What we offer

• Competitive salary of $80,000 per year.
• Minimal travel (1‑3 trips annually).
• Opportunity to lead a dedicated quality team in a global healthcare company.