Quality Assurance Specialist II
2 weeks ago
Second Shift (Afternoons)
Environmental Conditions:
Compliance with all Good Manufacturing Practices (GMP) Safety Standards is essential. Some degree of Personal Protective Equipment (PPE) is required, including safety glasses, gowning, gloves, lab coat, and ear plugs.
Job Overview:
Position Summary:
The individual in this role will be trained to execute the following responsibilities:
- Implement and uphold the efficiency of the quality management system.
- Examine incoming materials to verify compliance with approved specifications.
- Interpret technical drawings and specifications.
- Utilize measuring instruments for the assessment and inspection of materials.
- Document any nonconformances within the quality management system and engage in the DR/CAPA system as necessary.
- Conduct timely inspections of materials to ensure adherence to temperature requirements.
- Review laboratory testing data on raw materials and confirm re-control and/or expiration dates.
- Determine the disposition of materials based on inspection outcomes.
- Facilitate the movement of materials to and from Incoming Quality Assurance (IQA) both physically and electronically using SAP.
- Support management and the site in revising departmental processes for continuous improvement.
- Perform additional duties as assigned.
IQA Inspector II Responsibilities:
- Assist in the training of new team members.
- Make usage decisions for raw materials as required.
- Participate in Process Improvement initiatives and identify areas for enhancement.
- Complete Change Order training.
- Manage IQA team tasks, including supply requisitions and records management.
- Oversee the calibration of inspection instruments and devices.
- Ensure the IQA clean room is maintained according to plant procedures.
Minimum Qualifications:
A High School diploma or equivalent is required, along with a minimum of 3-5 years of relevant experience in Quality Assurance or Quality Control preferred. Familiarity with ISO 13485 and 21 CFR Part 820 is advantageous.
Knowledge of inspection principles and concepts is essential.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
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