Director of Quality bei undefined

This job description is intended to describe the nature and level of work being performed by employees assigned to this position. It is not to be construed as an exhaustive list of all responsibilities and duties required of the job incumbents. This position is designated as an FLSA exempt position.

Full time 

To explore the full range of benefits please visit our website www.jmmurray.com 

$40.60-$49.78/hour - Placement in the range will be determined based on experience and other factors allowed by law. 

GENERAL SUMMARY

This position is responsible for the overall design, implementation, and direction of the quality control/quality assurance and various engineering functions and systems of the agency’s business operations; management of all FDA compliance issues; continuous improvement projects while providing technical direction and assistance to all operational departments; and establishing and maintaining an ongoing culture of quality.  This position functions as the project lead for new initiatives including the installation of equipment; validations and testing methods; development and verification of accurate chemical methods; and maintenance of all COA (Certificates of Analysis) records for FDA regulations.  This position provides oversight for the ISO 9001:2015 program, and other certifications as applicable. 

COMPANY STANDARDS

• Maintain attendance and punctuality in order to present a positive role model for direct reports.  This position performs work functions on site and at any locations of operations. 
• Follow all safety rules and regulations; wear and/or use any required protective equipment while working; immediately report and work with Operations Management to resolve any safety concerns or unsafe working conditions.
• Ensure the JM Murray Quality System is maintained in a manner that ensures compliance to 21CFR 210 and 211; ensure compliance with all required regulations and guidelines in accordance with the JM Murray mission statement, policies and procedures. Adhere to all professional standards and governmental laws, rules and regulations.  
• Demonstrate both personal accountability and the development of confidence and accountability of their employees, to ensure that day to day issues and concerns are responded to and resolved in a timely manner.

ESSENTIAL FUNCTIONS

1. Oversee the development and review of specifications and quality requirements for new and existing products and materials, both internally and in conjunction with outside suppliers. 
2. Ensure that project and/or process control documentation is compliant with cGMP FDA requirements and/or customer contracts. Identify and develop measurement methods and collect, analyze, and publish performance data against defined parameters.
3. Review standard test procedures, quality records and validation techniques for laboratory testing. 
4. Perform raw material and compounded product testing which includes but is not limited to pH, viscosity, specific gravity, microbiological and organoleptic properties. Develop acceptability standards for raw material and finished product testing. 
5. Conduct investigations of specification raw material and compounded product that does not meet established standards. Responsible for ensuring that nonconforming material is dispositioned in a timely manner, in addition to analyzing defect trends in order to initiate appropriate corrective action and closure of non-conformances. 
6. Create machine set up, disassembly, cleaning and sanitizing procedures, and check sheets, and ensure proper training of all required personnel.
7. Ensure the creation and maintenance of all records associated with manufacturing methods, including engineered time studies used for commensurate wage calculations.
8. Prepare batch records for liquid filling and compounding. Document electronic information in various databases and internal programs for quality and statistical data analysis. 
9. Develop and implement methods and procedures for inspecting, testing, and evaluating the products and processes of suppliers 

10. Audit and monitor quality requirements in accordance with JM Murray quality assurance policies, regulatory agencies, and customer specifications. 
11. Ensure first article, in-process, in-coming and final inspections are completed and associated quality records of inspections are maintained. 
12. Responsible for reading, analyzing, and entering data for the environmental monitoring systems. 
13. Identify and lead continuous improvement projects (including but not limited to) lead-time reduction, direct/indirect labor cost reductions, and quality improvement.
14. Act as the key contact with customers' auditors and take responsibility for ensuring the execution of corrective actions and ongoing compliance with customers' specifications.
15. Assists with hiring of employees, ensuring that the most qualified applicants are selected for open positions. Participates in the decision making with regard to employees who require disciplinary actions and/or terminations. 
16. Provides ongoing feedback, coaching and supervision to direct reports with regard to job performance; completes timely performance reviews according to company expectations and timeframes.
17. Reviews and approves timecards for direct reports according to the JMM payroll schedule and current policies and procedures.
18. Attends all required training and meetings, in order to support and contribute to quality assurance and business operations.
19. Conducts self in a manner as to always contribute to maximum individual growth and in accordance with all regulations, the Code of Ethics and Company policy and procedures. Represents JM Murray and the JM Murray mission in a positive manner, treating people with respect and dignity.
20. Performs additional duties and responsibilities, as assigned.

COLLABORATION

INTERNAL 

JM Murray Management and Administration

JM Murray Operations employees and trainees

EXTERNAL

Customers

Suppliers/Vendors

EDUCATION and EXPERIENCE

Bachelors of Science in Engineering, Quality, or related discipline; 8 to 10 years of hands-on, varied, and progressive technical management experience in a regulated industry; American Society Quality Engineer Certification highly desired

KNOWLEDGE and SKILLS

Capable of working in a team-based setting providing guidance and expertise and knowledge, assisting in 

FDA or third-party quality system audits 

Advanced business writing and mathematical skills

Excellent verbal and written communication ability.

Proficient in specification and usage of Standard Measured Test Equipment 

Working knowledge of ERP systems and proficiency in Microsoft Office Suite, including EXCEL and data 

entry with proficient use of computers and other similar devices

WORKING CONDITIONS

Job assignments take place primarily indoors but also outdoors when traveling to pick up supplies, attend meetings or to work at other JM Murray locations. Environmental conditions include rain, snow and cold weather.

PHYSICAL REQUIREMENTS

APPLICANTS

I have reviewed this job description and I am able to perform the essential functions as outlined. I have discussed any questions I may have about this job description prior to signing this document.

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EMPLOYEE

I have reviewed this job description and I understand all of my job duties and responsibilities. I am able to perform the essential functions as outlined. I understand that my job may change on a temporary or regular basis according to the needs of my department without it being specifically included in the job description. I have discussed any questions I may have about this job description prior to signing this document.

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Director of Quality         V2025.09.18