Sr QA Technician

at  Thermo Fisher Scientific

JOB DESCRIPTION

Day Shift

EDUCATION:

• Minimum of HND in Quality or Science preferable.

EXPERIENCE:

Requires a minimum of two year’s QA/QC experience in a relevant environment. Knowledge of computer applications and current software (Word/ Excel) is essential.

• 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 level of inquiry
• Utilise Trackwise system – non conformances, 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.
• Utilise 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 to them
• May be required to perform other related duties as the need arises and/or assigned.