Job Snapshot
-
Employee Type:
Full-Time -
Location:
Cary, IL -
Job Type:
-
Experience:
Not Specified -
Date Posted:
2/5/2019 -
Job ID:
R411304
Job Description
Position Summary:
Under general supervision; this position will support the goals in processing incoming raw materials and components. The Incoming QA Technician I will be required to sample and inspect incoming raw materials against approved specifications and incoming inspection plans. The role will also serve as a point of contact/liaison and support routine Manufacturing operations.
Essential Duties and Responsibilities:
- Perform documentation activities that adhere to cGMP and GDP.
- Perform inspection activities for various raw materials, components & finished goods conformance to the specification or drawing.
- Sample and test received raw materials, components & finished goods that require inspection and release prior to use in manufacturing.
- Use of aseptic techniques to sample chemicals and raw materials.
- Use of various measurement tools and instruments: calipers, scales, thickness gauges, force gauges, optical comparator, Raman spectrophotometer, pipets, and other systems.
- Perform inspection activities of printed materials against master documents for differences.
- Initiation of Nonconformance investigative reports within the Agile/TrackWise systems.
- Maintain various spreadsheets and databases (requires heavy use of Excel, Word, MS Outlook and similar database programs).
- Communicate with Warehouse and Manufacturing personnel regarding the release and movement of materials/components.
- Communicate with various departments regarding the release status of materials.
- Update the release status of materials electronically to indicate acceptance or rejection.
- Perform other duties as assigned.
Education & Special Trainings:
- Associates Degree or equivalent job experience.
Qualifications & Experience:
- General knowledge of FDA regulations for drugs and medical devices.
- Exceptional organizational and communication skills.
- Ability to perform review of documentation with a high level of attention to detail.
- Ability to take direction, work independently and be adaptable in an ever-changing environment.
- Capability to handle heavy computer use and work in multiple systems.
- Proficiency with Microsoft Office (Word, Excel, etc.) required.
- Aptitude to multi-task and prioritize work.
- Possesses a high level of personal integrity and self-control.
- Physical capability to lift 60 pounds and be mobile throughout a large plant.
- Accepts direction and constructive criticism.
Physical Requirements:
- Subject to controlled indoor conditions with some temperature change from occasional task in the warehouse. May be subject to short-term exposure to some hazardous chemicals and reagents.
- Physical activities include: Standing, walking, sitting, lifting up to 60lbs, carrying, reaching, handling, talking, hearing, pulling, pushing, keying, grasping.
- Visual activities include: Must be capable of accurately discerning instrument/equipment displays. Good color discrimination.
Mental Requirements:
- Long periods of concentration including sample inspection, testing and review of documents. Participation in discussions and planning.