Incoming Materials QA Inspector - Precision & Compliance

International Executive Service Corps; Northern (KY); Hybrid; USD 57,000 - 62,000; Full time

Benefits offered by this job

Medical plans

Dental & vision insurance

401(k) match

Job summary

Fujirebio Diagnostics Inc. is seeking an IQA Inspector to perform incoming material inspections on-site and at the off-site warehouse, ensuring materials meet QA specifications and proper labeling.

The role involves documenting results, handling lot history, and supporting production packaging inspections. The candidate will have a high school diploma and at least 2 years in a regulated industry or QA, with knowledge of GMPs and strong organizational skills.

Qualifications

• Knowledge of quality assurance and incoming inspection.
• Must have knowledge of GMPs.
• Ability to interact with all levels within company.
• Ability to work in a deadline-oriented environment.
• Ability to handle work interruptions and perform in high stress situations.
• Excellent organizational skills and record keeping practices.
• Excellent communication skills.
• Detail oriented.

Responsibilities

• Performs incoming material inspections on-site and at the off-site warehouse, including labels and inserts, according to incoming quality assurance specifications and product labeling inspection procedures; determines the appropriate disposition of each material; labels all materials as to the correct status; assures proper storage conditions are maintained for incoming materials.
• Completes required documentation and updates electronic files as required to track material; works with lot history logs of all incoming material received.
• Works with master artwork files for production materials.
• Performs inspection(s) of first piece packaging for each kit packed and obtains the required retains as needed in support of QA production inspection.
• Verifies packaging of final kits by performing sampling inspections as needed in support of QA production inspection.
• Performs releasing transactions in the Inventory system when needed and performs receiving functions and adjustments associated with incoming materials.
• Performs containerization activities and transactions in the POMs system.
• Verifies information for in-house printed labeling; performs barcode scanning as necessary and verifies the information.
• Performs inspection and reconciliation of labeled components as needed in support of QA production inspection.
• Performs tasks associated with rework, written deviations and Stage II preproduction documentation.

Skills

Quality assurance

GMP knowledge

Documentation & record keeping

Attention to detail

Color vision

High stress tolerance

Education

High school diploma or equivalent

Level I QA/Incoming inspection experience

Job description

Fujirebio Diagnostics Inc. is seeking an IQA Inspector to perform incoming material inspections on-site and at the off-site warehouse, ensuring materials meet QA specifications and proper labeling.

The role involves documenting results, handling lot history, and supporting production packaging inspections. The candidate will have a high school diploma and at least 2 years in a regulated industry or QA, with knowledge of GMPs and strong organizational skills.