Inspector I - Quality Assurance-Columbus Quality

Scope

Primary Responsibilities/Accountabilities

• · Prepares and completes all start-up paperwork, and creates the shipper and lab labels required for the filling and packaging operations.
• · Reviews the customer’s Fill & Assembly (F&A) documents to ensure packaging specifications are followed for each product.
• · Performs quality checks at assigned frequencies to ensure all customer and regulatory specifications are met. Places any products not meeting the quality standards on hold for further quality review.
• · Records and processes quality-related information and paperwork in accordance with all applicable SOPs and WIs.
• · Performs and approves Line Clearances related to batch and fragrance changes.
• · Confirms and/ or verifies the Line Start-Up requirements are completed prior to the start of the filling and packaging operation.
• · Obtains First Production samples, KDC Replenishment samples, and Mast Replenishment samples as required per the customer’s SOP.
• · Communicates to the QA Lead and/or Line Lead all quality observations and concerns related to the filling and packaging operations.
• · Performs all work in a manner consistent with the company’s quality system, and FDA and GMP regulations, includes maintaining a clean, contaminant-free and orderly work area at all times.
• · Follows, promotes and enforces KDC’s safety and environmental policies, practices and procedures.
• · Performs other duties as assigned.

Education & Experience

Knowledge, Skills & Abilities

• Ability to adapt to rotating assignments with a positive attitude and results.