Quality Control Manager

POSITION OVERVIEW

The QC Manager is responsible for maintaining the quality and integrity of the compounded medications through managing product testing. In addition, they assist in all aspects of SOPs, testing, and inspections. The QC Manager demonstrates a commitment to the mission and goals of Belmar Select Outsourcing. This position is responsible for the direct supervision of Quality Control Personnel and reports to the Director of Quality.

RESPONSIBILITIES

• Direct supervision of a team of Quality Control personnel, including incoming materials technicians, quality control technicians, and quality control specialists.
• Correspond with contract laboratories to ensure timely receipt of results and direct path forward for OOS investigations.
• Manage sample submission and results review for tests performed at contract laboratories on incoming materials and finished products.
• Ensure timely processing of sterile loads to support product throughput.
• Define team objectives to ensure business deliverables are met.
• Ensure deviations, investigations, CAPA related to QC are closed in a timely manner.
• Ensure compliance to 21CFR 210 and 21CFR211 for all activities performed in QC.
• Represent QC in regulatory and state board of pharmacy audits.
• Monitor performance by gathering relevant data and producing statistical reports.
• Identify relevant training needs and delivering training.
• Formulate and manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to the QC.
• Maintaining awareness of the business context and company profitability, including budgetary control issues.
• Performs other duties as assigned.

PHYSICAL REQUIREMENTS

Additional Notes?

• Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time
• Must be able to wear required PPE for long periods of time when required.
• Position requires handling of laboratory chemicals or hazardous materials.
• Must be able to use necessary equipment such as computers, scanners, or other technology devices as assigned.