What are the responsibilities and job description for the IQA Inspector position at Fujirebio?
Position Summary: 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 (
Excellent attendance required
Ability to work overtime required
Education and Work Experience Required:
High school diploma or equivalent
Minimum of 2 years in a regulated industry, quality assurance or incoming inspection
The base salary range for this position is $55,000- $60,000/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.
We offer a competitive benefits package that starts on day one, including employer-paid dental & vision, 401(k) match up to 5%, and generous PTO and holiday benefits.
We regret we are not able to respond to each resume received. Only those selected for an interview will be contacted.
Fujirebio Diagnostics is an Equal Employment Opportunity Employer
Salary : $55,000 - $60,000