Clinical Quality Assurance Associate II (Non-Lab/Incoming Inspection)
at Thermo Fisher Scientific
Middletown, VA 22645, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 18 Oct, 2024 | Not Specified | 19 Jul, 2024 | 3 year(s) or above | Iso,Raw Materials,Records Management | No | No |
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Citizen | GC |
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Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
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Contract to Hire – Corp 2 Corp |
Description:
POSITION SUMMARY:
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.
- Use 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.
- 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 meaningful 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.
Responsibilities:
Please refer the Job description for details
REQUIREMENT SUMMARY
Min:3.0Max:5.0 year(s)
Pharmaceuticals
Production / Maintenance / Quality
Clinical Pharmacy
Diploma
Quality assurance or quality control preferred
Proficient
1
Middletown, VA 22645, USA