Manager, QA

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

Job Description

Position Summary:

This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. Responsible for supporting the Quality Systems and ensuring activities performed are following EU GMP and all other applicable local, regional or national regulations and standards. Perform QA and QC duties including physical inspection and documentation review to ensure Quality Management System compliance. Leads the local Quality team at the Bleiswijk facility.

Key Responsibilities:

Acts as named Quality person on licensing, as appropriate

Responsible for maintaining the QMS

Responsible for the Quality direction of the facility and assuring the facility is always audit ready.

Organisation and distribution of workload between Quality team staff

Prioritisation of work based on internal and external client requirements

Drafts, reviews and where required approves Quality Technical Agreement between FBS Netherlands and clients.

Developing and providing QA/QC training for Quality staff

Reporting performance metrics to Senior Manager, Quality

Responsible for management of the SOPs including EDMS, Archiving, and change control

Reviews and approves TrackWise PRs and lead investigations if required

Ensures that Internal Audits are performed and raises areas for improvement

Will perform Quality approval of suppliers for FBS Netherlands

Works to meet business goals set by senior management

Reviews and writes quality documents

Performs internal audits to assess compliance to the QMS and identifies required improvements

Ensures all job related paperwork is accurate and in line with Data Integrity requirements.

Supports risk management – including reviewing risk assessments

Analyses service and quality procedures to identify gaps and take corrective action

Ensuring all Quality tasks are performed in a timely manner and required timelines are met

Identify, raise and support investigations for any identified internal and/or external non-conformances

To ensure during review documentation is accurate, adheres to GMP, is error-free, and entered into operating systems appropriately

Perform additional duties, as assigned by Line Manager.

Minimum Requirements: The list below is representative of knowledge, skill and/or ability. To perform this job, the individual will be required to complete the following duties:

Requires effective verbally and written communication.

Ability to prepare reports using Excel; knowledge of Windows, Word required.

Ability to use Quality Management systems such as Trackwise, Documentum, etc

Knowledge of Universal Precautions, general laboratory and quality assurance/control required.

Requires demonstration of good professional judgment when working with clients.

Exhibits role model behaviour consistent with ThermoFisher values.

Can demonstrate strong logic and problem-solving skills.

Must be hard-working; able to function and complete tasks without continual oversight and direction.

Must have high level of integrity and reliability

Valid driver’s license and good driving record.

Requires ability to speak, read and write in English

Education / Experience:

University science degree preferred.

Experience in a GMP regulated environment.

Knowledge and understanding of European Clinical Trials Directives & Regulations.

Experience with, and implementation of cGMP’s, GLP, GCP, calibration, and validation.

Knowledge of general repository operations; shipping, receiving, cold temperature and stability storage.

Knowledge of local GMO regulations (preferred).

Work Conditions/Physical Requirements:

Ability to:

• Work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature.
• Use personal protective equipment and follow safety protocols.
• Lift and carry up to 50 lbs, and push up to 70 lbs.
• Process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C).
• Work in walk-in freezers or refrigerators periodically.
• To use a computer up to 7 hours per day.
• To travel to client sites as needed and assigned.

Employment is subject to 10 year 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.

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Thermo Fisher Scientific is an Equal Opportunities Employer and does not discriminate on the basis of race, colour, religion, sexual orientation, gender identity, national origin, disability or any other legally protected status.