Quality Coordinator II

SUMMARY

A Quality Coordinator II is responsible for supporting the QMS leader with the maintenance of a company's Quality Management System (QMS) by performing tasks like document control, internal auditing, data analysis, and ensuring compliance with quality standards, often including GMP and regulatory requirements, through activities like reviewing documentation, investigating quality issues, and training employees on quality procedures; essentially acting as a participating contributor to maintaining a robust quality system at multiple sites within an organization.

DUTIES AND RESPONSIBILITIES

May include, but are not limited to, the following:

• Document control: Coordinating and updating quality documents like Standard Operating Procedures (SOPs), specifications, and work instructions, ensuring accuracy and proper distribution.
• Internal auditing: Participate in regular internal audits with lead auditors to assess compliance with quality standards, identifying non-conformances, and initiate corrective actions.
• Data analysis: Review quality data from production processes, identifying trends, and reporting findings to management.
• Quality event management: Support investigating deviations, out-of-specification results, and other quality events to determine root cause and implement corrective actions.
• Training support: Assisting with the development and delivery of quality-related training programs for employees when needed.
• Supplier quality management: Review supplier documentation and perform supplier audits to ensure quality standards are met.
• Compliance: Support compliance programs at site related to quality including ISO, responsible care, GMP, and sustainability reporting.
• Record keeping: Maintain accurate and complete quality records, including batch records, test results, and non-conformance reports.
• Ability to work independently as well as part of a team.
• Strong attention to detail and ability to identify errors
• Ability to work effectively on your own initiative and with a can-do attitude.
• Proactive, strong organizational, project and stakeholder management skills.
• Must be able to communicate well.
• Perform additional duties as assigned.

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• High School Diploma is required
• Two years of experience in a manufacturing environment in operations, maintenance or quality is required
• Associate’s degree is preferred
• Experience/knowledge in Quality Management systems and/ or Sustainability preferred
• ISO experience is strongly preferred
• Must have excellent computer skills
• Must be able to travel up to 25%

PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to sit and work on a computer, stand; use hands to finger, handle, or feel; and reach with hands and arms. The employee frequently is required to walk; stoop, kneel, crouch, or crawl; and talk or hear. The employee is occasionally required to sit and climb or balance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.

WORK ENVIRONMENT

Capable of working in office, plant and lab environment. Manufacturing environment includes: dust, outdoors, high noise levels.