Job Description

　　Company Information

　　About Thermo Fisher Scientific

　　As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer! We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

　　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 sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　Job Description

　　Job Title: Lead QA Technician

　　Reports To: Quality Manager

　　Group/Division: ThermoFisher Scientific / BioPharma Services Division

　　Career Band: 4

　　Job Track: Associate

　　Position Location: Bleiswijk, Netherlands

　　Number of Direct Reports 0

　　Day/Shift (if applicable): Avg 40 hrs per week/ rotating 7 day/week shift pattern

　　Position Summary:

　　Included in the daily responsibility, is supporting the implementation and maintenance of quality systems and ensuring that FBS NL adheres to all site applicable EU GMP, IGJ and other identified applicable regulations! Working a rotating 7 day a week shift pattern, you will be responsible for ensuring compliance to the Quality Management System and to provide support to the Quality Manager where required.

　　Key Responsibilities:

　　SOP Management, including Document Control as Coordinator on eDMS

　　Reviewing and where required, approving Trackwise QRs

　　Reviewing and where appropriate approving draft operational documentation

　　Performing Quality review of change controls

　　Responsible for status control of products/material

　　Manages items and content on SFLMS

　　Performing Supplier assessment

　　Assures compliance to company QMS and any other applicable regulations/standards

　　Assures compliance to EU GMP and IGJ regulations to ensure retention of site licenses

　　Performs required duties as an approved Archivist

　　Performs verification as the need arises.

　　Supports Client audits and Internal Audit Programs where required

　　Delivers training and performs competency assessments for other QA staff

　　Checking completed operational documentation for ALCOA+ and adherence to Good Documentation Practices, where appropriate Quality approving documentation.

　　Performs QA related tasks as assigned by the Quality Manager

　　Performs QC functions as the need arises.

　　Travels as the need arises.

　　May be required to perform off site work where as the need arises.

　　Minimum Requirements/Qualifications:

　　Educated to degree level or equivalent in relevant subjects and/or has at least 1 years GMP experienceEssential Skills/Experience:

　　A high degree of accuracy and attention to detail

　　Ability to read and interpret general procedures and government regulations

　　Good problem solving skills

　　Ability to optimally present information and respond to questions from groups of managers, clients and inspectors

　　Ability to calculate figures and amounts such as proportions, percentages, area and volume

　　Good computer knowledge, proficient in MS Office (Word, Excel, and PowerPoint) and ability to acquire knowledge and master all clinical trial database systems

　　Good verbal and written communication

　　Builds good working relationships with other employees and external individuals.

　　Able to work under pressure and to support others within the team

　　Employment is subject to 10 year history screening for criminal records, qualifications, previous employment and credit history – Thermo Fisher Scientific have the right not to employ people failing to meet the standards required

　　This position functions in a repository environment, which may include working with dry ice, liquid nitrogen cryogenics, hazardous and infectious agents as well as marked changes in temperature

　　Proficient in English

　　Although not essential, the following would be preferable:

　　Valid driver’s license and a good driving record

　　Live no more than 30 minutes driving time from the facility

　　Signatures:

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.