IQA Inspector

For 75 years, Fujirebio Diagnostics Inc. is a leading worldwide biotechnology company and the innovation engine behind diagnostic breakthroughs that reach patients globally. 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 innovation, clinical evidence, and global CDMO partnerships, ensuring next-generation biomarkers are accessible across diagnostic platforms.

About the role

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.

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.
• 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.

Requirements

• Knowledge of quality assurance and incoming inspection
• Knowledge of GMPs
• Ability to interact with all levels within the company
• Ability to work in a deadline-oriented environment
• Ability to handle work interruptions and perform in high-stress situations
• 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

Qualifications

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

Pay

The base salary range for this position is $57,000–$62,000 per 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.

Schedule

The typical work schedule for this position is a 4-day work week, Monday to Thursday.

Benefits

• Competitive benefits package starting 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
• Employee Assistance Program (EAP)
• Generous Paid Time-Off and paid holidays
• Opportunity for advancement