Coating Place
QA Supervisor - Compliance
Coating Place, Verona, Wisconsin, United States, 53593
Position Overview
The primary role of the QA Supervisor - Compliance is to provide compliance, technical, and validation guidance for the company to ensure compliance with internal procedures and policies as well as US and International guidance. The QA Supervisor - Compliance will assist with day-to-day quality processes, identify and coordinate quality initiatives, and drive any necessary improvement efforts.
Essential Job FunctionsProvide oversight and leadership to Quality Assurance employees focused in areas including but not limited to compliance, nonconformance (e.g., OOS, OOC, etc.) change control, deviations, CAPA, SOPs, food safety and validation.Assists in maintaining QMS software and other QA software systems as needed.Mentors, trains, and oversees all team members with a focus on development to help achieve personal and company goals.Provide guidance and review on validation activities throughout the company including computer systems, manufacturing equipment, analytical equipment, utility systems, cleaning and process validation.Identify areas of improvement and propose new solutions designed to increase efficiency and performance within the quality assurance department.Resolve compliance and validation challenges by using creative and flexible thinking.Create and revise applicable SOPs.Assists with metrics and reports related to the quality system. Provides suggestive mediation of identified gaps and metrics that might impact business objectives.Provide support to the development, implementation and review of food safety systems including but not limited to Food Safety plans, Food Allergens and Environmental Monitoring.Support quality investigations as necessary.Assist in responding to audit observations from regulatory agencies and clients as needed.Maintain compliance with all company policies, plans, and procedures, including safety, security, and regulatory.Employees at CPI work with and/or are familiar with the GMP requirements for Food, Dietary Supplements, Pharmaceuticals, or other elements of each.Depending on the position, the employee will be aware of Halal and/or Kosher requirements.Other duties as assigned.Education/Skills/Knowledge Required
7+ years of direct experience with a quality function and/or quality related responsibilities is preferred. Advanced degree or other formal quality training may be substituted in place of experience.2+ years previous supervisory or management experience or related role is preferred.Applicable certifications for food regulatory requirements (PCQI, SQF, etc.) are preferred.Demonstrates the ability to work with others efficiently and effectively either one-on-one, as a team, or in a group.Possesses a positive attitude with self-motivation.Knowledge of computer systems and pertinent software, particularly Microsoft Office, LIMS Software, and QMS Software.Knowledge of quality management systems, food safety systems, and Regulatory Requirements.Basic technical knowledge and understanding of facilities, equipment, and quality systems within a pharmaceutical, dietary, supplement, and/or food setting.Experience in planning, coordinating, and executing multiple projects simultaneously.Outstanding written, verbal, and interpersonal communication skills required.Strong attention to detail.Competitive Benefits:
Medical, Dental, Vision, Life, AD&D, and Disability Insurance401K PlanTuition Reimbursement ProgramPaid-time Off - Accrue up to 17 days of PTO within the 1st year!
The primary role of the QA Supervisor - Compliance is to provide compliance, technical, and validation guidance for the company to ensure compliance with internal procedures and policies as well as US and International guidance. The QA Supervisor - Compliance will assist with day-to-day quality processes, identify and coordinate quality initiatives, and drive any necessary improvement efforts.
Essential Job FunctionsProvide oversight and leadership to Quality Assurance employees focused in areas including but not limited to compliance, nonconformance (e.g., OOS, OOC, etc.) change control, deviations, CAPA, SOPs, food safety and validation.Assists in maintaining QMS software and other QA software systems as needed.Mentors, trains, and oversees all team members with a focus on development to help achieve personal and company goals.Provide guidance and review on validation activities throughout the company including computer systems, manufacturing equipment, analytical equipment, utility systems, cleaning and process validation.Identify areas of improvement and propose new solutions designed to increase efficiency and performance within the quality assurance department.Resolve compliance and validation challenges by using creative and flexible thinking.Create and revise applicable SOPs.Assists with metrics and reports related to the quality system. Provides suggestive mediation of identified gaps and metrics that might impact business objectives.Provide support to the development, implementation and review of food safety systems including but not limited to Food Safety plans, Food Allergens and Environmental Monitoring.Support quality investigations as necessary.Assist in responding to audit observations from regulatory agencies and clients as needed.Maintain compliance with all company policies, plans, and procedures, including safety, security, and regulatory.Employees at CPI work with and/or are familiar with the GMP requirements for Food, Dietary Supplements, Pharmaceuticals, or other elements of each.Depending on the position, the employee will be aware of Halal and/or Kosher requirements.Other duties as assigned.Education/Skills/Knowledge Required
7+ years of direct experience with a quality function and/or quality related responsibilities is preferred. Advanced degree or other formal quality training may be substituted in place of experience.2+ years previous supervisory or management experience or related role is preferred.Applicable certifications for food regulatory requirements (PCQI, SQF, etc.) are preferred.Demonstrates the ability to work with others efficiently and effectively either one-on-one, as a team, or in a group.Possesses a positive attitude with self-motivation.Knowledge of computer systems and pertinent software, particularly Microsoft Office, LIMS Software, and QMS Software.Knowledge of quality management systems, food safety systems, and Regulatory Requirements.Basic technical knowledge and understanding of facilities, equipment, and quality systems within a pharmaceutical, dietary, supplement, and/or food setting.Experience in planning, coordinating, and executing multiple projects simultaneously.Outstanding written, verbal, and interpersonal communication skills required.Strong attention to detail.Competitive Benefits:
Medical, Dental, Vision, Life, AD&D, and Disability Insurance401K PlanTuition Reimbursement ProgramPaid-time Off - Accrue up to 17 days of PTO within the 1st year!