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Clinical Quality Assurance Associate Ii
3 months ago
**Business Card Title: IQA Inspector II**
**Job Profile Title**:QC Technician II, IQA**
**Reports To**: Team Leader, QC**
Group/Division: CDD/SDG
Job Track: Associate
Job Family: Operations
Job Sub-Family: Quality Control
Job Band: 02
Job Code: OPS.QCOP.A02
Location: Middletown, Virginia
No. of Direct Reports: 0
Shift: Mid-shift 10AM-6:30PM
FLSA Status: Non-Exempt
***
The incumbent must be trained and can perform the following processes:
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Inspect incoming materials to determine if they meet approved specifications.
- Interpret drawings and part specifications.
- Utilize measuring instruments to measure and inspect materials.
- Document nonconformances in the quality system and participate as needed in the DR/CAPA system.
- Inspect materials in a timely manner to ensure necessary temperature requirements are maintained.
- Review testing data performed by the laboratory on raw materials and verify re-control and/or expiration dates assigned.
- Disposition materials for use based upon the outcome of the inspection.
- Move materials to and from IQA both physically and electronically in SAP.
- Assist management and site with revision of departmental processes to ensure continual improvement.
- Performs other duties as assigned.
**IQA Inspector II Requirements**:
- Assist in training new personnel.
- Perform usage decisions for raw materials as needed.
- Participate in PPI events and identify process improvements.
- Complete Change order training.
- Cross train in Manufacturing Quality Control Specialist role.
- Be responsible for IQA team tasks such as supply requisitions and records management.
- Manage calibration of inspection instruments and devices.
- Ensure IQA clean room is maintained in accordance with plant procedures.
**Minimum Requirements/Qualifications**:
- High School graduate or equivalent with a minimum of 3-5 years relevant experience in Quality Assurance or Quality Control preferred.
- Experience and knowledge of ISO 13485 and 21 CFR Part 820 preferred.
- Familiar with inspection principles and concepts.
