Quality Assurance Auditor I (Indy)

Colorcon Inc • Indianapolis, IN

3d • Onsite

About The Position

The Quality Assurance (QA) Auditor I is responsible for batch review and release and assists in investigation of reported product quality issues and internal non-conformance issues. The QA Auditor I is also responsible for meeting all other tasks assigned via their yearly goals set by the Quality Supervisor. The position reports to the Quality Supervisor.

Requirements

• Bachelor’s degree in a physical science preferred or a minimum of 2 years quality auditing experience required.
• Ability to work comfortably in the manufacturing area.
• Ability to communicate effectively at all levels verbally and in written reports.
• Consistent attention to detail.
• Excellent organizational and decision-making skills.

Nice To Haves

• Experience in technical writing strongly preferred.
• Prior experience in problem solving techniques highly desirable.

Responsibilities

• Aware of GMPs and GLPs and maintains compliance with those regulations
• Performs batch review and product release activities for the Indianapolis site
• Prepares paperwork for samples being sent to the QC laboratory.
• Supports sending samples for external testing.
• Assists with internal quality audits
• Perform quality review/audit of incoming raw materials and finished products.
• Supports the investigation of customer reported product quality issues, internal non-conformance (INC) issues and other manufacturing deviations or problems.
• Partners with quality control, operations, engineering, maintenance, safety and supply chain to ensure appropriate and timely determination of scope, product impact, root cause and corrective actions of product quality issues, INC issues and other manufacturing deviations.
• Fosters collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of INC issues.
• Documents all investigation activities in detailed, timely reports utilizing Colorcon’s Customer Support Solution (CSS).
• Responsible for initiating INC service Requests (SRs)
• Issue necessary quality paperwork for SR related operations.
• Assists with new hire training for employees
• Assists with document retention.

Benefits

• All employees are eligible to participate in our company-wide bonus program
• Employees have the choice between three medical plans
• 100% company-paid Dental Insurance for all employees and their qualifying dependents
• Optional Vision Coverage
• Fitness and Wellness Programs
• Employee Assistance Programs (EAP)
• Corporate Social Responsibility Groups (CSR)
• Parental Leave
• Tuition Reimbursement; up to $8,000 per calendar year
• 401(k) Company Matching
• Paid Time Off
• Paid Holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees