Job Description

Associate Scientist Bacteriology Lab Operations

Job Overview:

Responsible for performing routine analysis and laboratory testing procedures to obtain data for use in drug development and clinical trials research.

Essential Functions:

• Responsible for performing and documenting analytical procedures in accordance with SOPs and regulatory guidelines.
• Performs routine data analysis to determine if an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances.
• Identifies and documents potential performance errors or otherwise unusual results and escalates to senior lab personnel.
• Prepares data analysis results for upload to LIMS system under the guiadance of senior level staff.
• Assists in quality investigations, deviations, and resolution.
• Prepares buffers and solutions for analysis, as required.
• Assists in the review and update of laboratory procedures and techniques.
• Guides entry level staff on routine procedures and supports on-boarding of new staff.
• Performs and document calibration and maintenance of laboratory equipment as assigned.
• Performs and documents hands on training for other lab personnel in areas of proven competency as assigned.
• Assists in the review and development of laboratory procedures and techniques.
• Assists in the implementation of procedural changes as assigned.
• Notifies inventory staff of supply shortages.
• May represent lab team on cross functional projects.
• Responsible for clear, accurate, and timely communications with cross functional stakeholders.
• Participates in continuing education through self-study, attending training sessions and lectures and meetings.
• Supports safety, quality, and 6S requirements and initiatives.
• Complies with company\'s procedures and applicable regulatory requirements.

Qualifications:

• Bachelor\'s degree in Immunology, Biochemistry, Biology or Microbiology or related scientific field, or other equivalent combination of education and experience
• 6 months of experience in a regulated laboratory environment.

• Knowledge of working aseptically (e.g. Biological Safety Cabinet);
• Aseptically maintain cell line cultures as required;

• Demonstrates understanding of functional area and responsibilities.

• Working knowledge of any applicable regulatory standards within area of responsibility, such as Good Laboratory Practices (GLP).
• Proficiency with relevant laboratory techniques.
• Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling.
• Experience working with automation or specialized laboratory equipment.
• Proficiency with routine and some non-routine laboratory calculations regarding batches and specimens including averages, means, standard deviations, and various quality control metrics.
• Good computer skills using Microsoft Outlook, Word and Excel.
• Capable of handling multiple tasks simultaneously.
• Strong attention to detail and accuracy.
• Ability to effectively collaborate with internal stakeholders.

Scientifique associ\xc3\xa9 Op\xc3\xa9rations du laboratoire de bact\xc3\xa9riologie \xe2\x80\x8b

Aper\xc3\xa7u du poste:

Responsable de l\'ex\xc3\xa9cution des analyses de routine et des proc\xc3\xa9dures d\'essais en laboratoire pour obtenir des donn\xc3\xa9es \xc3\xa0 utiliser dans le d\xc3\xa9veloppement de m\xc3\xa9dicaments et la recherche d\'essais cliniques.

Fonctions essentielles:

• Responsable de l\'ex\xc3\xa9cution et de la documentation des proc\xc3\xa9dures analytiques conform\xc3\xa9ment aux SOP et aux directives r\xc3\xa9glementaires.
• Effectue une analyse de routine des donn\xc3\xa9es pour d\xc3\xa9terminer si une proc\xc3\xa9dure analytique se d\xc3\xa9roule conform\xc3\xa9ment aux attentes et si les r\xc3\xa9sultats se situent dans des tol\xc3\xa9rances acceptables.
• Identifie et documente les erreurs de performances potentielles ou les autres r\xc3\xa9sultats inhabituels et les transmet au personnel sup\xc3\xa9rieur du laboratoire.
• Pr\xc3\xa9pare les r\xc3\xa9sultats de l\'analyse des donn\xc3\xa9es \xc3\xa0 t\xc3\xa9l\xc3\xa9charger dans le syst\xc3\xa8me LIMS sous la direction du personnel de niveau sup\xc3\xa9rieur.
• Aide aux enqu\xc3\xaates de qualit\xc3\xa9, aux d\xc3\xa9viations et \xc3\xa0 la r\xc3\xa9solution.
• Pr\xc3\xa9pare les tampons et les solutions pour analyse, au besoin.
• Aide \xc3\xa0 l\'examen et \xc3\xa0 la mise \xc3\xa0 jour des proc\xc3\xa9dures et des techniques de laboratoire.
• Effectue et documente l\'\xc3\xa9talonnage et l\'entretien de l\'\xc3\xa9quipement de laboratoire tel qu\'assign\xc3\xa9.
• Effectue et documente la formation pratique d\'autres membres du personnel de laboratoire dans les domaines de comp\xc3\xa9tence \xc3\xa9prouv\xc3\xa9s assign\xc3\xa9s.
• Aide \xc3\xa0 l\'examen et au d\xc3\xa9veloppement des proc\xc3\xa9dures et des techniques de laboratoire.
• Avertit le personnel d\'inventaire des p\xc3\xa9nuries d\'approvisionnement.
• Responsable des communications claires, pr\xc3\xa9cises et opportunes avec les parties prenantes interfonctionnelles.
• Participe \xc3\xa0 la formation continue par l\'auto-apprentissage, en assistant \xc3\xa0 des sessions de formation, des conf\xc3\xa9rences et des r\xc3\xa9unions.
• Se conforme aux proc\xc3\xa9dures de l\'entreprise et aux exigences r\xc3\xa9glementaires applicables.

Ce que nous recherchons :

• Baccalaur\xc3\xa9at en immunologie, biochimie, biologie ou microbiologie ou dans un domaine scientifique connexe, ou autre combinaison \xc3\xa9quivalente d\'\xc3\xa9tudes et d\'exp\xc3\xa9rience
• 6 mois d\'exp\xc3\xa9rience dans un environnement de laboratoire r\xc3\xa9glement\xc3\xa9.

• Connaissance du travail aseptique (ex. Cabinet de s\xc3\xa9curit\xc3\xa9 biologique);
• Maintenir aseptiquement les cultures de lign\xc3\xa9es cellulaires selon les besoins ;

• D\xc3\xa9montre une compr\xc3\xa9hension du domaine fonctionnel et des responsabilit\xc3\xa9s.

• Connaissance pratique de toutes les normes r\xc3\xa9glementaires applicables dans le domaine de responsabilit\xc3\xa9, telles que les bonnes pratiques de laboratoire (BPL).
• Ma\xc3\xaetrise des techniques de laboratoire pertinentes.
• Connaissance des proc\xc3\xa9dures et pratiques de s\xc3\xa9curit\xc3\xa9 en laboratoire et de contr\xc3\xb4le des infections, y compris les pr\xc3\xa9cautions standard et la manipulation de produits chimiques dangereux.
• Exp\xc3\xa9rience de travail avec l\'automatisation ou l\'\xc3\xa9quipement de laboratoire sp\xc3\xa9cialis\xc3\xa9.
• Ma\xc3\xaetrise des calculs de routine et de certains calculs de laboratoire non routiniers concernant les lots et les \xc3\xa9chantillons, y compris les moyennes, les moyennes, les \xc3\xa9carts-types et diverses mesures de contr\xc3\xb4le de la qualit\xc3\xa9.
• Bonnes comp\xc3\xa9tences informatiques avec Microsoft Outlook, Word et Excel.
• Capable de g\xc3\xa9rer plusieurs t\xc3\xa2ches simultan\xc3\xa9ment.
• Grand souci du d\xc3\xa9tail et de la pr\xc3\xa9cision.
• Capacit\xc3\xa9 \xc3\xa0 collaborer efficacement avec les intervenants internes.

Q\xc2\xb2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

IQVIA