Job Title: QC Manager

Job Description

We are looking for an experienced Quality Control Manager to lead our QC team and ensure the production of top-quality products. This role involves managing Quality Control operations and collaborating with various departments. You will be responsible for supporting product development, stability testing, process improvements, equipment validation, and meeting production targets. Additionally, you will uphold our company's standards and quality policies.

Responsibilities

• Supervise Quality Control personnel with a moderate to high level of oversight.
• Directly manage the Reagent Quality Control section.
• Participate in and lead cross-functional teams.
• Ensure the availability of facilities, resources, and equipment to meet production goals.
• Support product development, stability testing, process improvements, and equipment validation.
• Ensure adherence to production schedules.
• Uphold company standards and quality policies.

Essential Skills

• Quality control management.
• Corrective and Preventive Actions (CAPA).
• Managing non-conformances.
• Laboratory skills in molecular biology and microbiology.
• Good Manufacturing Practices (GMP).

Additional Skills & Qualifications

• Bachelor's Degree in Chemistry, Biological Sciences, or a related field.
• 8+ years of leadership experience in Quality Operations.
• 10+ years of experience in FDA regulated or ISO certified environments.
• Strong mathematical skills, knowledge of ISO and FDA Quality Systems.
• Experience with Manufacturing Resource Planning systems like Oracle or SAP.
• Preferred certifications: ASQ CQM, CQE, or Six Sigma

Work Environment

You will work in a complex manufacturing setting with both small and large production runs. Our environment is ISO certified and involves FDA-regulated products. The role requires teamwork and interaction with global colleagues. You will contribute to work that impacts patient care and be part of a diverse and inclusive culture that values your perspective and supports your professional growth.