Corporate Quality Manager

Job Summary:

Responsible for the management and oversight of the Quality Management System at certified group. Responsible for application and evaluation of approved microbiological and chemical techniques and methodologies used in analysis of products and possess the authority to carry out these tasks, training, as well as ensuring compliance with the ISO / IEC 17025, USDA, 21 FDA CFR & 21 CFR part 11 guide for testing laboratories.

Essential Responsibilities:

1. Participate in maintenance of regulatory certifications (USDA, FDA 21 CFR, ISO/IEC 17025) in all divisions.
2. Improve and ensure Quality Management Systems is in compliance with GMP, GLP, and regulatory certifications (USDA, FDA 21 CFR, ISO/IEC 17025).
3. Maintain frequent contact with all Quality personnel; review the reporting, and interpretation of laboratory quality control and other quality critical records in all areas of the facilities. Work closely in the daily functions associated with the maintenance of the quality system.
4. Perform corporate and report audits of all quality system documentation and personnel for general quality system compliance, food microbiology/food chemistry and laboratory quality system documents including methodology and work instructions
5. Assist in collecting and producing reports on Quality metrics data from the network for tracking and continuous improvement purposes
6. Assist in maintaining the QMS system with updates and other functions as appropriate
7. Responsible for ensuring preparedness for surveillance audits as they occur and work closely with each facility Laboratory Manager and Technical Manager as the key contact for external auditor.
8. Have the ability to provide hands on training on all parts of the quality system as needed and requested.
9. Play a key role identifying improvement strategies that can reduce errors within the network as it relates to quality.
10. Follow up major and critical audit findings to ensure that appropriate actions have been taken, and that the issues identified, have adequately been resolved.
11. Provide on the bench training when appropriate
12. Ability to interpret technical data and provide summarization.

Education & Experience:

• MS degree in Microbiology, Chemistry, Food Technology, or related field
• Excellent written and verbal communication skills
• Laboratory / technical auditing experience preferred
• Analytical Chemistry experience preferred
• Knowledge of ISO 17025, CFR Part 11, CFR part 21 and FDA standards
• Hands on experience in a microbiological and chemical testing environment
• 2 years’ experience in a commercial testing laboratory
• Or equivalent combination of education and experience
• Knowledge of Lean Six Sigma or similar processes aimed at process efficiencies

Language Skills:

• Read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Write reports, business correspondence and procedure manuals
• Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public

Mathematical Skills:

• Work with mathematical concepts such as probability and statistical inference
• Apply concepts such as fractions, percentages, ratios and proportions to practical situations

Reasoning Ability & Independent Judgment:

• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Have critical and strategic thinking abilities
• Have the ability to work independently or in a team environment

Supervision (As assigned):

• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems

Physical Demands/Work Environment:

• Dexterity of hands and fingers to operate a computer keyboard, mouse and to handle other communications/computer components
• Noise level varies from quiet to loud
• Temperature varies from hot to cold
• Interactive and fast-paced team-oriented tasks
• Extensive overnight travel is required
• Occasionally lift and/or move up to 25 pounds
• Color vision and depth perception

Activity

Amount of Time

None

Under 1/3

1/3 to 2/3

Over 2/3

Stand

x

Walk

x

Sit

x

Use hands to finger, handle, or feel

x

Reach with Hands and Arms

x

Climb or balance

x

Stoop, kneel, crouch, or crawl

x

Talk or hear

x

Color vision and depth perception

x

General Requirements:

• Strong organizational skills and ability to execute manual detailed tasks
• Flexible schedules
• Ability to analyze and interpret data
• Prolonged sitting, viewing of computer screens
• Work under stress with interruptions and deadlines
• Ability to think logically
• Required to wear appropriate protective clothing and equipment
• Responsible for the safety of oneself and others
• Ability to travel as needed by the organization
• Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens
• Noise level varies from quiet to loud
• Temperature varies from hot to cold
• Interactive and fast-paced team-oriented tasks