Quality Specialist

Position: Quality Specialist

Reports to: Quality Manager

Summary: The Quality Specialist will support the manufacturing process by ensuring quality records meet standards by managing, reviewing, and archiving controlled documents. They will assist with the handling of change controls and verifying internal and external compliance. The Quality Specialist will have strong attention to detail and computer skills to maintain an accurate and accessible quality system.

Responsibilities:

· Follow standard operating procedures and quality directives as outlined by the IKI Quality Manual.

· Review and verify blending and production work orders to ensure documentation accuracy, completeness, and compliance with internal standards, and external regulations and requirements.

· Create, maintain, and update work orders to ensure control of approved documents with the most accurate instructions and compliance with customer specifications.

· Issue work orders to the blending and production teams based on the production schedule.

· Process temporary and permanent change requests for controlled documents and approved processes.

· Review new and revised customer product specifications and update the production management software, as well as applicable documents, appropriately.

· Assist with the maintenance and continuous improvement of the QMS, including but not limited to RCAs, CAPAs, SCARs, NCRs, and change controls.

· Prioritize workload to align with production and distribution plans.

· Perform other duties as assigned.

Required Skills & Abilities:

· Excellent attention to detail and thoroughness.

· Ability to thrive in a fast-paced environment.

· Strong organizational and prioritization skills.

· Strong math skills with the ability to read, interpret, and correlate data.

· Excellent computer skills, with strong familiarity with the MS Office suite and Adobe.

· Ability to communicate effectively cross-functionally.

Education & Experience:

· High school diploma, or equivalent, required.

· Associate’s or bachelor’s degree, preferred.

· Quality assurance experience required.

· Experience with contract manufacturing process preferred.

Work Environment: Office environment with occasional exposure to the manufacturing areas and laboratory with exposure to chemicals. Proper PPE must be worn, and safety precautions must be followed when in applicable areas.

Physical Demands: Sits 75%, stands 25%, occasional lifting up to 50 lbs.