IQA Inspector

International Executive Service Corps; Northern (KY); On-site; 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

About Us:

For 75 years, Fujirebio Diagnostics Inc., is a leading worldwide biotechnology Company and the innovation engine behind diagnostic breakthroughs that reach patients worldwide. Our in vitro diagnostics (IVD) technology powers critical tests across the globe’s leading diagnostic platforms. We are a biomarker and diagnostic content provider that strengthens diagnostics for everyone. Through our approach of innovation, clinical evidence and global CDMO partnerships, we ensure that next-generation biomarkers are accessible across diagnostic platforms, so patients benefit no matter which system is used.

Position Summary:

The IQA Inspector is responsible for performing incoming material inspections and ensures that all incoming materials meet all acceptance and quality criteria. Ensures that inspections of packaging and labeling operations are performed in accordance with recognized quality standards and internal operating procedures.

Essential Job Functions:

• 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.
• Assures sufficient retains are taken of raw materials during incoming inspection; maintains raw material storage area; performs disposal of expired raw material.
• Maintains OEM shipment retain inventory that is provided by logistics; performs disposal of expired OEM material.
• Handles disposal of materials that are expired, obsolete or dispositioned as scrap.
• Controls production materials, assures only the current, effective revision is available to the production floor.
• Works with Purchasing to process returned and/or rejected dispositions; assures proper labeling and storage of materials not meeting incoming specifications.
• Assists with routine monitoring and maintenance of laboratory equipment as required by pertinent SOPs.
• Supports QA with complaint and non-conformance investigations.
• Follows all company environmental, health and safety policies, procedures and guidelines, and conducts work in a safe manner.
• Performs other duties as assigned.

Job Specifications (skills, knowledge, special training, certification, license requirements):

• 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
• Ability to drive – valid driver’s license required
• Excellent organizational skills and record keeping practices
• Ability to multi-task and prioritize work
• Ability to accurately document, transcribe and verify information and data
• Excellent communication skills
• Detail oriented
• Excellent keyboard/PC skills
• Ability to perform visual inspections and differentiate colors
• Light lifting (= 30 lbs.)
• Excellent attendance required
• Ability to work overtime required

Education and Work Experience Required:

• High school diploma or equivalent
• Level I: Minimum of 2 years in a regulated industry, quality assurance or incoming inspection

The base salary range for this position is $57,000- $62,000/year. The actual base pay offered may vary depending on multiple factors, including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. The typical work schedule for this position is a 4-day work week, Monday to Thursday.

We offer a competitive benefits package that starts on day one, including three medical plans, savings and spending accounts, employer-paid dental & vision, 401(k) match up to 6%, life insurance and disability, educational assistance, EAP, generous Paid Time-Off, paid holidays, and opportunity for advancement.

Fujirebio Diagnostics is an Equal Employment Opportunity Employer