The Quality Control I Inspector performs quality control inspections, checks, and test during the manufacture of products. Inspect materials, parts and products at different stages of production. Records observations and make recommendations for improving processes in support of the Quality Systems and manufacturing processes.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Responsible for all activities involving quality inspections and compliance with applicable regulatory requirements.
- Establish and monitor inspection criteria for incoming materials and distribution of finished products.
- Performs all aspects of testing related to manufacturing (Incoming inspections, First article inspections, In-process release inspection, Final QC release of finished goods and Document review).
- Ensures that all inspections and procedures are properly completed and documented.
- Develop and manage the batch review and disposition process for in-process and finished products.
- Monitor and analyze nonconformities, coordinate the implementation of corrective and preventive actions, verify effectiveness and monitor supplier qualification plan.
- Develop, review and approved label specifications. Maintain label control and printing operations.
- Perform pre and post-inspection of product gamma irradiation process.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
High School diploma or equivalent with 0-2 years’ experience in the quality control inspections under FDA GMP.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
To perform this job successfully, an individual should have knowledge of MS Access Database software; Internet Explorer Internet software; MS Excel; Spreadsheet software and MS Word Processing software.
Certificates, Licenses, Registrations
Current driver's license, Quality certificate or equivalent training is desirable.