Director of Quality

J.M. Murray Center, Inc.•Munsons Corners, NY

3d•$84,450 - $107,993•Onsite

About The Position

Want to work at a great place with a social mission? JM Murray is a unique organization with two interconnected divisions; Business Division and Services Division. Together, these divisions create meaningful employment opportunities for individuals with disabilities. The Business Division of JM Murray provides contract services in manufacturing and assembly, packaging and distribution. We also offer a complete line of dental and personal care products. We are registered with the FDA as a medical device manufacturer, contract liquid filler and manufacturer of personal care products. We currently compound and fill 4 ADA approved toothpaste formulas. JM Murray is hiring a full-time Director of Quality who will lead and oversee the Quality Department. The Director of Quality is the company lead and responsible for the overall design, implementations, and direction of the Quality Management System. You will ensure FDA compliance throughout our operations, lead and provide continuous improvement projects and provide technical direction and assistance to all operational departments; establishing and maintaining an ongoing culture of quality. This position functions as the company 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 records for FDA regulations. This position provides oversight for the ISO 9001:2015 program, and other certifications as applicable. 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.

Requirements

Bachelors of Science in an applicable field or 5 to 10 years of hands-on, varied, and progressive quality management experience in a regulated industry.
Capable of working in a team-based setting providing leadership and expertise and knowledge, leading 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.

Nice To Haves

Experience within Pharma FDA operations with an ISO background is highly desirable.
American Society Quality Engineer Certification highly desired

Responsibilities

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.
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.
Review standard test procedures, quality records and validation techniques for laboratory testing.
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.
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.
Create machine set up, disassembly, cleaning and sanitizing procedures, and check sheets, and ensure proper training of all required personnel.
Ensure the creation and maintenance of all records associated with manufacturing methods, including engineered time studies used for commensurate wage calculations.
Prepare batch records for liquid filling and compounding. Document electronic information in various databases and internal programs for quality and statistical data analysis.
Develop and implement methods and procedures for inspecting, testing, and evaluating the products and processes of suppliers
Audit and monitor quality requirements in accordance with JM Murray quality assurance policies, regulatory agencies, and customer specifications.
Ensure first article, in-process, in-coming and final inspections are completed and associated quality records of inspections are maintained.
Responsible for reading, analyzing, and entering data for the environmental monitoring systems.
Identify and lead continuous improvement projects (including but not limited to) lead-time reduction, direct/indirect labor cost reductions, and quality improvement.
Act as the key contact with customers' auditors and take responsibility for ensuring the execution of corrective actions and ongoing compliance with customers' specifications.
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.
Provides ongoing feedback, coaching and supervision to direct reports with regard to job performance; completes timely performance reviews according to company expectations and timeframes.
Reviews and approves timecards for direct reports according to the JMM payroll schedule and current policies and procedures.
Attends all required training and meetings, in order to support and contribute to quality assurance and business operations.
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.
Performs additional duties and responsibilities, as assigned.