QA Change Control Lead — Quality Systems

Kansas Ag Connection; Elwood (NY); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Multiple relocation packages

8-week parental leave

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Kansas Ag Connection is looking for a Quality Assurance Associate - Change Control Coordinator in Elwood, New York. This role involves coordinating the change management process and collaborating with various teams to ensure compliance with quality standards.

The ideal candidate will have a Bachelor's degree and at least 8 years of experience in Quality Assurance within a regulated industry. Knowledge of change control and root cause analysis is essential for success in this position.

Competitive benefits such as flexible work arrangements and parental leave are offered.

Qualifications

• 8 years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.).
• Strong expertise in change control and root cause analysis.
• Ability to manage cross-functional quality initiatives in a GMP-regulated environment.

Responsibilities

• Coordinate and oversee daily activities within the site change management system.
• Lead or support Change Review Board (CRB) activities.
• Drive change controls to closure in a timely and compliant manner.
• Support deviation investigations, including root cause analysis and CAPA development.
• Write, revise, and maintain QA procedures and controlled documents.

Skills

Change control expertise

Root cause analysis

Quality documentation review

Technical writing

Collaboration skills

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office

Electronic Quality Management Systems (eQMS)

Job description

Kansas Ag Connection is looking for a Quality Assurance Associate - Change Control Coordinator in Elwood, New York. This role involves coordinating the change management process and collaborating with various teams to ensure compliance with quality standards.

The ideal candidate will have a Bachelor's degree and at least 8 years of experience in Quality Assurance within a regulated industry. Knowledge of change control and root cause analysis is essential for success in this position.

Competitive benefits such as flexible work arrangements and parental leave are offered.