Description

Position Purpose:

The Quality Control Manager is responsible for overseeing Gilchrist & Soames' quality control program. The primary goal of this role is to ensure that the products, services, and processes of the organization meet the required standards of quality and that the organization is meeting its customer requirements.

Primary Responsibilities:

• Manage the daily workload and safety of the quality control staff. Oversee colleague relations and participate in staff selection, performance and compensation evaluations, corrective actions and terminations.
• Develop, revise, and review SOPs, qualification/validation protocols and reports.
• Oversee the day-to-day operations of the quality control program, including inspections, tests, and audits. Willing and capable to work as a backup QC analyst for testing activities as needed.
• Conduct regular internal and external quality control audits to ensure compliance with established standards and procedures.
• Identify and investigate quality control issues and recommend solutions to improve the quality of products and processes. Conduct investigations regarding out of specifications (OOS) results and address and manage deviations. Participates and leads continuous improvement initiatives.
• Work closely with the production, engineering, and R&D teams to ensure that quality control considerations are integrated into the design, development, and production processes.

Education:

• Bachelor's degree in biology, Microbiology, or other laboratory-based life science, or ten years' experience in Quality Control.
• Deep experience with leading Quality initiatives, participating in certification and regulatory audits, and developing CAPA responses to audit observations.
• Certification as Certified Quality Auditor (QCA) through American Society for Quality, a plus.
• Six Sigma Certification, a plus.

Experience:

• 5 years' experience in a Quality Control environment with knowledge of cGMP regulations and some background in microbiology.
• 2 years' experience leading and developing a team.

Skills:

• Excellent analytical and mathematical skills.
• Basic knowledge of quality engineering and statistics.
• Excellent communication (verbal and written), interpersonal and professional interactive skills are necessary to perform at a high degree of proficiency. Ability to effectively coach, present information and respond to questions from management, inter-department staff and suppliers. Capable of working with internal staff from other departments in a proactive and constructive manner.
• Ability to mentor and develop individuals and teams. Able to engage and lead team discussions and meetings. Understands team dynamics and works well within a team structure. Collaborative management style. Delegates responsibilities effectively.
• Strong organizational and project management skills, including the ability to plan, prioritize and execute multiple initiatives/deadlines autonomously and shift priorities, as necessary. Able to manage large, complex projects. Uses time effectively.
• Customer Service - Respond promptly to requests for service and assistance as needed. Follow up as needed.
• Problem Solving - Identifies and resolves problems in a timely manner. Gathers and analyzes information skillfully. Develops alternative solutions.
• Judgment - Displays willingness to make decisions. Exhibits sound and accurate judgment. Makes timely decisions.
• Professionalism - Approaches others in a tactful manner. Reacts well under pressure. Follows through on commitments.
• Detail Oriented - Attention to details and accuracy.
• Ability to understand and execute all relevant policies and procedures in a consistent, timely and objective manner.
• Solid understanding of quality systems standards, benchmarking, audit systems, concepts, practices, methodologies and procedures within the Quality field.
• Proficient use of MS Office (Word, Excel, PowerPoint and Outlook) and statistical tools.