Lead QA Technician

Work Schedule

Flex Shifts 40 hrs/wk

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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 as per the requirements as per the Quality Management System and to provide support to the Quality Manager.

Key Responsibilities:

• SOP Management, including Document Control as Coordinator on eDMS
• Quality Reviewing and as 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
• Ensures 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 part of Quality.
• Supports Client audits and Internal Audit Programs where required
• Provides training and conducts proficiency 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 site Head of Quality.
• Performs QC functions as per required daily activities.
• Travel might be required.
• May be required to perform off site work in line with work requirements.

Minimum Requirements/Qualifications:

• Educated to degree level / equivalent in relevant subjects and/or has at least 1 years GMP experience

Required 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 efficiently 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 teamworks with site employees and external individuals.
• Able to operate 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 required, 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