TalentBridge is proud to partner with an amazing team dedicated to producing high-quality, safe, and compliant products that make a difference every day. We are looking for a strong Quality Control Manager to take the lead in driving quality assurance processes, ensuring compliance with cGMP regulations, and fostering a culture of operational excellence. This role offers a unique opportunity to collaborate with passionate professionals, contribute to innovation, and make a meaningful impact in a dynamic and fast-paced environment. Join our partner's exceptional team and bring your expertise to a rewarding role where quality truly matters.

Key Responsibilities :

• Supervise and lead the QC team within the facility, ensuring proper training, adherence to cGMP standards, and alignment with business needs.
• Develop and maintain an appropriate staffing model to efficiently meet organizational goals and objectives.
• Conduct performance reviews, provide feedback, and implement development plans for QC personnel.
• Review formulation records and related documentation to ensure compliance with procedures and acceptance criteria.
• Oversee the development and adherence to sampling instructions, test methods, quality control procedures, and SOPs.
• Approve and monitor testing conducted by third-party laboratories.
• Ensure maintenance, calibration, and validation of QC equipment and processes are performed and documented.
• Investigate and resolve issues related to product deviations, analytical failures, complaints, and out-of-specifications (OOS).
• Contribute to strategic planning by analyzing quality trends and identifying opportunities for improvement.
• Monitor quality operations, including production, productivity, and customer service standards.
• Assist with budget preparation, expense management, and financial variance analysis.
• Prepare quality documentation, including reports on failed processes, stability studies, corrective actions, and validations.
• Stay informed of industry developments and integrate best practices into QC processes.
• Work cross-functionally with other department leaders to support company growth through innovative thinking and implementation of new concepts, products, and services.
• Represent the company professionally at conferences and during interactions with regulatory bodies and customers.
• Directly oversee QC Associates, providing guidance, support, and development opportunities while ensuring compliance with cGMP requirements.

Qualifications & Skills :

LI-JM