Clinical Quality Assurance Associate II

at  Thermo Fisher Scientific

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.

Please refer the Job description for details