Regulatory Compliance Officer
2 weeks ago
Job Summary:
We are seeking a highly skilled Quality Assurance Specialist to join our team at Thermo Fisher Scientific. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our products and processes.
Key Responsibilities:
- Maintain a thorough understanding of regulatory and quality system requirements, including ISO13485 and FDA CFR.
- Develop and maintain Standard Operating Procedures (SOPs) and ensure their compliance with regulatory requirements.
- Review and verify batch manufacturing documentation to ensure accuracy and completeness.
- Enter and check data in our system to ensure accuracy and compliance.
- Compile customer documentation packages and provide customer-facing responses to inquiries.
- Utilize Trackwise system for non-conformances, deviations, and CAPA.
- Provide training and support to QA staff and other departments as needed.
- Participate in personal development to improve skills and knowledge relevant to the position.
- Utilize Agile system for project management.
- Upload SOPs and WINs to the Training System.
- Record archiving and maintain a clean and organized quality document storage area.
Requirements:
- Minimum of HND in Quality or Science.
- Minimum of two years' QA/QC experience in a relevant environment.
- Knowledge of computer applications and current software (Word/Excel).
Working Conditions:
This role will work in an office environment but may require spending time in manufacturing and the warehouse. Must be able to work overtime to complete daily tasks.
About Us:
Thermo Fisher Scientific is a leading innovative company that offers competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. We value diversity, integrity, intensity, involvement, and innovation in our employees and offer outstanding career and development prospects.
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