Clinical Quality Assurance Associate II

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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

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.

• 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.