Quality Assurance Specialist
1 day ago
Job Summary
The ideal candidate will be responsible for reviewing and verifying all documentation related to finished goods products, highlighting any inconsistencies or problems with quality or compliance prior to final product release.
Main Responsibilities
- Maintain solid understanding of Regulatory and Quality System requirements (ISO13485/FDA CFR).
- Prepare new SOPs and edit/delete revised Standard Operating Procedures.
- Review of all batch manufacturing documentation, required in advance of final product release.
- System data entry and data checks.
- Compile customer documentation packages.
- Provide customer-facing responses to all levels of inquiry.
- Utilize Trackwise system – nonconformances, deviations, CAPA.
- Provide training and support to other QA staff as required, as well as other departments within operations.
- Participate in personal development to further improve skills and knowledge relevant to the position.
- Utilize the Agile system.
- Upload SOP/WIN's to the Training System.
- Record archiving, routine filing, and responsible for housekeeping of all quality document storage areas.
- Appropriate PPE must be worn and used in accordance with the instructions provided.
- May be required to perform other related duties as the need arises and/or assigned.
Requirements
- Minimum of HND in Quality or Science preferable.
- Requires a minimum of two years' QA/QC experience in a relevant environment. Knowledge of computer applications and current software (Word/Excel) is essential.
Working Conditions
Works in an office environment but may be required to spend some time in manufacturing and the warehouse. Must be able to work overtime to complete daily tasks.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
At Thermo Fisher Scientific, we value diverse experiences, backgrounds, and perspectives. If you're looking for a challenging and rewarding career, we encourage you to explore our current opportunities and apply today.
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