OVERALL PURPOSE/FUNCTION:

Quality management is an essential aspect of every successful organization. A dedicated Quality Manager ensures products and services meet the highest customer standards.

This role requires an understanding of both quality assurance and control. Core responsibilities include managing QMS (Quality Management System) to meet customer expectations, inspecting products, providing guidance to team members and liaising with project managers and customers. The Quality Manager ensures that our products meet customer requirements and industry standards to support the ongoing success and growth of the company.

This position will oversee quality operations to ensure methods and materials produce a safe, high-quality product that is reproducible in manufacturing using proscribed methods and procedures. The person filling this position will provide strategic direction, technical expertise, and leadership for MCP’s Quality Department.

This position oversees accurate and efficient analytical data collection, Good Manufacturing Practices (cGMP), timely and appropriate release of Raw Material (RM) lots, Bulk Formula (BF) batches, and Finished Goods (FG) lots.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following. Other duties may be assigned.

This position requires knowledge of:

 Monitoring and managing individual growth of staff through collaborative growth plans for each employee.

 Monitoring departmental efficiency taking / recommending steps for improving organization design and work processes.

 Establishing open lines of communication for routine information dissemination and open discussion of events with staff.

 Ensure training of personnel to meet company/customer requirements and equip team members with the necessary skills to succeed.

 Maintain personnel performance evaluations, communicate job expectations, and motivate team members to excel.

 Ensure compliance for regulated products following established test methods and procedures to meet FDA, EPA and micro-susceptible product and process requirements.

 Develop processes to inspect the quality of products, ensuring they meet company standards and customer specifications.

 Striving for continuous improvement of products and processes to reduce expenses by preventing defects through the use of Self Improvement and Cost Saving plans.

 Technical aptitude and advanced problem-solving skills to resolve issues by investigating circumstances, identifying solutions, and implementing corrective action plans.

 Constructing and executing quality assurance protocols that provide guidance and support to team members.

 Ensure projects are completed within the allotted timeframe and budget.

 Provide guidance and support to project teams and project managers concerning quality requirements.

 Manage, plan and direct quality functions to provide support for Operations while ensuring compliance with protocols, cGMP, GLP, Good Documentation Practices, and safety regulations.

 Reviewing testing data and authorizing release of RM lots, BF batches, and FG lots

 Ability to draw conclusions from data and communicate those conclusions verbally and in writing.

 Able to work independently and manage personnel and resources with minimal supervision.

 Ensuring that positions within the groups under direct control are filled with qualified individuals.

 Handling all administrative tasks involved with salaried staff and ensuring that such tasks for hourly personnel within the Department are handled by appropriate Supervisory personnel.

 Ensuring that the resources of the Quality functions including, but not limited to, consumables, equipment, and overtime are utilized appropriately and efficiently to reduce waste and maximize safety, productivity, and efficiency.

 Writing, reviewing, and/or approving documents including, but not limited to, Standard Operating Procedures (SOPs), and Work Instructions (WIs), and forms, logs, and training materials (as necessary) for such documents.

 Developing, maintaining, and overseeing the execution of validation protocols.

 Executing and approving all Out-of-Specification (OOS) investigations

 Acting as Lead or Associate Investigator and/or providing inspection, analytical, or other support as required for Out of Specification (OOS), Deviation, and/or Corrective and Preventive Action (CAPA) investigations.

 Reviewing and analyzing Operations related metrics (KPI’s) and reports then recommending / undertaking appropriate corrective measures regarding productivity and efficiencies

 Performing periodic review of data and generating data figures and trends, and evaluating and presenting those and other results to MCP’s Senior Level Staff (SLS)

 Ensuring compliance with company policies and objectives and cGMPs by performing / assisting with both announced and unannounced internal audits of company departments and systems

 Assisting the VP of Quality and R & D as a primary resource during outside audits and regulatory inspections.

 Leading strategic, budgetary, and departmental growth and development plans. For the quality department and assisting/advising the VP of Quality and R & D with same.

 The above duties and responsibilities are representative of the nature and level of work assigned and are not necessarily all-inclusive.

QUALIFICATIONS/REQUIREMENTS:

Education and/or Experience

 Bachelor’s degree in science, engineering, chemistry, or another appropriate field. An advanced degree in the life sciences is preferred, but not required.

 A minimum of five (5) years’ experience in a quality or life science role (Analytical/Microbiological) within a manufacturing environment.

 A minimum of five (5) years’ managerial experience, seven (7) years’ supervisory experience, or an appropriate combination is preferred.

 FDA/EPA/Regulatory Experience and Knowledge

 Intermediate or better computer skills (e.g. MS Office including Excel and Word) are essential access is a plus.

 Math skills and computer skills (e.g. MS Office including Excel and Word) are essential.

Professional Designations / Licensures / Certifications

 ASQ Membership/Certification- preferred.

 Six Sigma Certification – preferred.

Skills, Knowledge and Abilities

 Leadership

 Detail-orientation.

 Adaptability

 Analysis

 Emotional intelligence

 Resilience

 Creativity

 Data analysis and reporting

 Process improvement and optimization.

 Risk management.

 Excellent Communication Skills: written and verbal.

This position description reflects the current assignment of essential functions and is not meant to be all-inclusive. Duties and responsibilities may be assigned or reassigned to this job at any time, and may be modified to reasonably accommodate an individual with a disability, or for other reasons.

Job Type: Full-time

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Relocation assistance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Hickory KY

Work Location: In person