Quality Assurance Inspector – I – 2nd Shift

Scope: The Quality Inspector I performs all operations related to the inspection of finished products in accordance with all applicable customer and regulatory requirements, Standard Operating Procedures (SOP), Work Instructions (WI) and Good Manufacturing Practices (GMP).

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:
High school diploma/GED with proficiency in math.

Minimum of one year experience in a quality-related role preferably in a manufacturing and FDA regulated environment.

SAP experience preferred.

Knowledge, Skills & Abilities:
Ability to adapt to rotating assignments with a positive attitude and results.

Strong computer skills (Microsoft Office).

Strong problem solving, decision making, analytical and technical skills.

Comprehensive understanding of FDA Good Manufacturing Practices Regulations (GMP’s) and OSHA safety requirements.

Self-starter with strong work ethic and attention to detail.

Strong communication (both written and oral), interpersonal, team building and organizational skills.

Ability to perform multiple tasks simultaneously and manage time efficiently and effectively.

Ability to plan ahead to minimize potential issues as well as to meet company growth objectives.

Must be able to understand and complete procedure documents in accordance with SOPs and WIs.

Ability to use measuring and testing devices.

Minimum Requirements:
Must be 18 years or older.

Able to work overtime & weekends as required.

Wear hairnet, safety glasses, long pants, steel toe shoes/boots and any other uniform standards.

Read, comprehend and follow written and verbal instructions, including SOPs.

Sit, bend, stoop, climb, and stand for long periods of time in one place.

Lift items up to 50 lbs.

Exposure to a variety of cleaners and sanitizers, hot water and chemicals.