Quality Director
New Albany, OH, United States
SUMMARY / OBJECTIVE
Responsible in overseeing all the departments and the staff responsible for the control and assurance of quality, provide technical support for Production and Customer Service and implement well-integrated quality programs to safeguard product safety and quality.
ESSENTIAL FUNCTIONS
Oversees Quality Control Laboratory Operations including analytical chemistry, microbiology, environmental monitoring, and product stability testing
Oversees Quality Assurance functions including final product release, exception management, product complaint handling, and manufacturing process monitoring activities, internal assessment, and annual product review
Direct the cGMP quality programs and regulate policies, goals, and objectives for the company to uphold quality standards
Partner with manufacturing and business leaders to continuously improve processes
Manage fiscal responsibility for the Quality Department budget
Training for department and oversee general training for personnel.
Represent the company in GMP, customer and regulatory audits, format responses and initiate corrective actions.
COMPETENCIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
N/A
SUPERVISORY RESPONSIBILITIES
Directly oversees the management of the following departments: Quality Assurance, Quality Control, and Microbiology. Responsibilities include interviewing, hiring and training employees; planning and assigning, directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually moderate.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee frequently is required to stand, to walk; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision ability required by this job includes close vision, color vision, depth perception, and ability to adjust focus.
POSITION TYPE/EXPECTED HOURS OF WORK
Exempt position; no overtime
Forty (40+) plus hours per week expected; weekends as needed
TRAVEL
Facility or external vendors/partners
REQUIRED EDUCATION & EXPERIENCE
Bachelor's degree (B.S./B. A) from a four-year college or university in chemistry or related science. Advanced degree desirable. Minimum of 7 years Quality Management experience.
PREFERRED EDUCATION & EXPERIENCE LANGUAGE SKILLS
MATHEMATICAL SKILLS: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and soled geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
ADDITIONAL ELIGIBILITY QUALIFICATIONS
REASONING ABILITY : Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret and extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
WORK AUTHORIZATION
Must be authorized to work in the U.S. as a pre-condition of employment.
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