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2 jobs found
21.11.2025
WP

West Pharma Tech Sup Laboratory LN France

Limitless High-tech career opportunities - Expoint
Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs). Uses critical thinking skills to analyze field failures to identify the root...
Description:
Job Summary
In this role, you will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques. You may be assisting in developing procedures for instrumentation, test instructions, and test reports. You may coordinate the day-to-day receipt and shipment of samples in the laboratory and support the Laboratory team in administration and quality systems.
Essential Duties and Responsibilities
  • Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
  • Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
  • Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
  • With guidance, assist in completing projects from protocol to final report.
  • Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
  • Train new analysts as appropriate.
  • Exercises creativity in developing new test / debugging methods.
  • Keep current with new analytical techniques and technology.
  • Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
  • Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
  • Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
  • Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
  • Support laboratory management in data quality-documentation, and archiving.
  • Maintain compliance to cGMP and ISO requirements and established safety procedures.
  • May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.
  • May handle Test Requests – write, review, and approve, and maintain traceability of samples.
Education
  • Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
  • High School Diploma required
Work Experience
  • No min required 0 - 3 years of experience required and
  • Experience working in a laboratory or cGMP/pharmaceutical environment preferred
  • Laboratory administrative/Coordinator/Analyst role preferred
Preferred Knowledge, Skills and Abilities
  • Support and contribute to Lean Sigma programs and activities towards delivery of the set target
  • Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
  • Method development and validation
  • Willingness to learn and apply new analytical techniques
  • Proficient in Microsoft Office tools and capable to learn other software programs
  • Able to review regulatory code and learn safety standards
  • Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
  • Able to comply with the company’s safety and quality policies at all times
Additional Requirements
  • Must be able to stand for long periods of time
  • Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
  • Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
  • Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
  • Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
  • Read and interpret data, information and documents
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to follow directions, multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Observe and interpret situations, analyze and solve problems
Show more
06.09.2025
WP

West Pharma Jr Engineer Quality Assurance LN France, Hauts-de-France

Limitless High-tech career opportunities - Expoint
Représenter le département qualité au sein des équipes projets. Assurer la conformité des nouveaux équipements et programmes avec les exigences de qualité. Participer aux projets d'amélioration, en visant particulièrement l'amélioration...
Description:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Nous recherchons un(e) Ingénieur Junior, Assurance Qualité pour soutenir les programmes CAPEX de notre usine et s'assurer de leur conformité avec les exigences de qualité. Vous développerez des analyses de données et une approche préventive pour améliorer les stocks bloqués et le Coût de la Mauvaise Qualité (CoPQ). Vous serez également chargé(e) d'une partie des validations qualité et veillerez à ce que le système qualité respecte les normes West et les standards applicables. Vous appuierez les processus de laboratoire afin d'assurer leur conformité aux exigences de qualité.

Tâches et Responsabilités Essentielles :

P rogrammes CAPEX de l'usine :

  • Représenter le département qualité au sein des équipes projets.
  • Assurer la conformité des nouveaux équipements et programmes avec les exigences de qualité.

Amélioration continue :

  • Participer aux projets d'amélioration, en visant particulièrement l'amélioration du coût de non Qualité.
  • Gérer et apporter des améliorations à la gestion des stocks bloqués (produits finis, semi-finis, matières premières).
  • Analyser les risques : Contribuer au contrôle des risques en participant aux analyses de risques et en proposant des actions.

Gestion des processus qualité :

  • Veiller à la définition, la mise en place, la capitalisation et l'efficacité des processus qualité, et proposer des plans d'actions pour améliorer la performance des processus qualité.
  • Gérer les processus qualité à travers des indicateurs clés de performance (KPI) en Europe et à LN.
  • Participer à la gestion qualité des fournisseurs.
  • Audits internes :
    • Réaliser une partie des audits selon le plan annuel.
    • Assurer le suivi des audits internes réalisés
    • participer aux r evues Annuelles de Produits pour les produits Westar®.

Validations :

  • Participer, si nécessaire, aux validations décrites dans le SVP (expertise sur la méthode, participation aux AMDECs, etc.).
  • Examiner et approuver les dossiers de validation.

Support au laboratoire :

  • Examiner et approuver les écarts du laboratoire.
  • Examiner et approuver les résultats hors spécifications.

Travail selon les règles GMP :

  • Assurer le respect strict des règles et la bonne application des procédures, notamment en matière d'hygiène personnelle, de propreté, de manipulation des produits et de contamination croisée sur les articles mélangés.

Qualifications de Base :

  • Diplôme de Master en Ingénierie QA ou formation équivalente avec solide bagage technique.
  • Première expérience en tant qu'apprenti ou mission de courte durée en AQ industrielle est un atout.

Connaissances, Compétences et Aptitudes Préférées :

  • Bonne connaissance des réglementations qualité et BPM.
  • Maîtrise de l'anglais à l'écrit et à l'oral requise.
  • Bonne pratique de Microsoft Office et SAP.
  • Excellentes compétences en communication orale et écrite.
  • Sens des compétences interpersonnelles et du travail d'équipe.
  • Bonne présentation générale.
  • Compétences analytiques et esprit d'initiative requis.

Job Summary

The Jr Assoc, Quality Assurance will support Quality activities within a multi-functional team environment for medical devices. The role will provide analytical support within the Quality team and will assist with projects and tasks in support of business needs and will play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria.The role will also execute transactions in relevant GMP systems (Master Control, SAP, Share Point) and other relevant quality functions as applicable including site audit support.

Essential Duties and Responsibilities

  • Assist in structuring and formatting documentation to ensure compliance to procedures, relevant regulations and standards.
  • Assist teams in the development DHF and DMR documents, specifically in regards to facilitating document control activities.
  • Work collaboratively with internal customers to refine and optimize analysis and reporting criteria as well as manage expectations around analysis delivery timelines and output capabilities
  • Assist with tracking, documenting, and reporting quality notification activities including but not limited to Failure Investigations, CAPAs, Non-Conformance assessments, audit findings and deviations.
  • Support the development of QMS procedures and work instructions.
  • Work cross-functionally with individuals and project or extended teams to ensure success of projects.
  • Drive solutions to ensure internal customer related problems/issues are communicated.
  • Establish routine communication strategies for project tracking and prioritization
  • Assure escalation of quality related issues to ensure effective remediation
  • Identify training needs and take action to ensure company wide compliance.
  • Provide training and support to team members that covers systems, policies, procedures, and core processes.
  • Liaison with company and customers on Quality matters
  • Other duties as assigned

Additional Responsibilities

Education

  • Bachelor's Degree Life Science or equivalent. preferred

Work Experience

  • No min required 2 years similar experience. preferred

Preferred Knowledge, Skills and Abilities

  • Able to be aware of all relevant SOPs as per Company policy and Quality Manual
  • Able to comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times.

License and Certifications

Travel Requirements

None: No travel required

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.

Show more

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Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs). Uses critical thinking skills to analyze field failures to identify the root...
Description:
Job Summary
In this role, you will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques. You may be assisting in developing procedures for instrumentation, test instructions, and test reports. You may coordinate the day-to-day receipt and shipment of samples in the laboratory and support the Laboratory team in administration and quality systems.
Essential Duties and Responsibilities
  • Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
  • Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
  • Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
  • With guidance, assist in completing projects from protocol to final report.
  • Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
  • Train new analysts as appropriate.
  • Exercises creativity in developing new test / debugging methods.
  • Keep current with new analytical techniques and technology.
  • Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
  • Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
  • Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
  • Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
  • Support laboratory management in data quality-documentation, and archiving.
  • Maintain compliance to cGMP and ISO requirements and established safety procedures.
  • May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.
  • May handle Test Requests – write, review, and approve, and maintain traceability of samples.
Education
  • Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
  • High School Diploma required
Work Experience
  • No min required 0 - 3 years of experience required and
  • Experience working in a laboratory or cGMP/pharmaceutical environment preferred
  • Laboratory administrative/Coordinator/Analyst role preferred
Preferred Knowledge, Skills and Abilities
  • Support and contribute to Lean Sigma programs and activities towards delivery of the set target
  • Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
  • Method development and validation
  • Willingness to learn and apply new analytical techniques
  • Proficient in Microsoft Office tools and capable to learn other software programs
  • Able to review regulatory code and learn safety standards
  • Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
  • Able to comply with the company’s safety and quality policies at all times
Additional Requirements
  • Must be able to stand for long periods of time
  • Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
  • Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
  • Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
  • Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
  • Read and interpret data, information and documents
  • Must maintain the ability to work well with others in a variety of situations
  • Must be able to follow directions, multi-task, work under time constraints, problem solve, and prioritize
  • Ability to make independent and sound judgments
  • Observe and interpret situations, analyze and solve problems
Show more
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