Quality Control Technician / Technicien(ne) Contrôle de la qualité

MSD; Charlottetown; On-site; CAD 45,000 - 77,000; Full time

Job summary

A leading company in life sciences seeks a Quality Control Technician in Charlottetown. This role involves performing Work in Process (WIP) testing and batch release testing, alongside stability testing and environmental assessments, ensuring compliance with Good Manufacturing Practices (GMP) and quality standards. Candidates should possess relevant experience and skills in microbiology and molecular biology, ideally with a Scientific Diploma.

Benefits

Health care benefits

Paid holidays

Retirement benefits

Bonus eligibility

Qualifications

• One or more years of experience in GMP/ISO environment.
• Proficient oral and written communication skills required.
• Able to comply with Manufacturing Directions and Standard Operating Procedures.

Responsibilities

• Conduct all Work in Progress and Final Product batch release tests.
• Perform Environmental Monitoring tests and utilities testing.
• Assist in validation work and update Standard Operating Procedures.

Skills

Analytical Problem Solving

Microbiological Cultures

Molecular Biology

Quality Control Processes

Time Management

Education

2 year college diploma in science related discipline

Bachelor’s degree in a Science related discipline

Tools

MS Word

MS Excel

Job description

Pay Competitive

Location Charlottetown/Prince Edward Island

The Quality Control Technician is responsible for performing Work in Process (WIP) testing of all antigens, and batch release testing in accordance with approved Outlines of Production and Good Manufacturing Practices. In addition, the Quality Control technician is responsible for stability testing, environmental and utility testing, and qualification / validation activities as required.

Functions, Duties and Tasks :

Testing :

Performing all Work in progress and Final Product batch release tests within the scope of the Outlines of Production, according to Good Manufacturing Practices principles.

Methods include, but are not limited to microbiology, cell culture, and molecular biology techniques.

Performing Enviromental Monitoring tests and utilities testing for all departments.

Performing Stability testing.

Assisting in validation work as required.

Equipment validations.

Method validations.

Update / maintain / create relevant Standard Operating Procedures, Source of supplies, Manufacturing Defect Forms and forms.

Quality Control Department Support:

Recognize and report any Out of Scope or deviations to Quality Control Manager.

Initiate and complete investigations where applicable.

Interactions with production departments to ensure results are communicated.

Occasional after-hours work, and on-call schedule.

Ability to work within all Quality systems (including Trackwise, Regulus, Sharepoint).

Maintaining inventory of reagents and expiry checks of materials.

A dditional duties as required.

A 2 year-year college diploma in science related discipline.

Required Experience and Skills:

One or more years of experience working in a Good Manufacturing Practices/International Organization of Standardization environment.

Proficient oral and written communication skills.

Able to follow/comply with Manufacturing Directions, Standard Operating Procedures, Company/Corporate/Regulatory Policies.

Ability to demonstrates basic skills in effective time management to meet given deadlines.

Able to work effectively with team members and show initiative to support others on the team when needed.

Proficient computer skills including MS Word and MS Excel.

Preferred Education, Experience and Skills:

A Bachelor’s degree in a Science related discipline

Experience with one or more of the following areas: Molecular Biology, Microbiology (Bacterial), Microbiology (Viral)

Experience performing investigations and assisting in deviations.

A good understanding of aseptic processes.

Experience using quality improvement tools and continuous improvement processes and site quality metrics.

Advanced mathematical skills preferred.

Other Requirements and Information:

Must be able to work a flexible schedule, including evenings, weekends, and overtime as required.

Required to assist in disinfection procedures involving hazardous chemicals requiring the use of a respirator.

Must be able to move and maneuver small-medium sized equipment.

Requires ability to stand for long periods of time.

Must be able to read, write, understand, and comply with appropriate standard operating procedures.

All candidates are required to have adequate and legal work authorisation to work in Canada, prior to applying for posted positions.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

The Company is required to provide a reasonable estimate of the salary range for this job in certain provinces within Canada. Final determinations with respect to salary will consider a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected CAD salary range: $45,100 - $76,700. Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, and vacation.

All candidates are required to have adequate and legal work authorization to work in Canada, prior to applying for posted positions. Only candidates with valid work authorization, not requiring company sponsorship in the course of their employment with our company will be considered in the recruitment process.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Job Description

The Quality Control Technician is responsible for performing Work in Process (WIP) testing of all antigens, and batch release testing in accordance with approved Outlines of Production and Good Manufacturing Practices. In addition, the Quality Control technician is responsible for stability testing, environmental and utility testing, and qualification / validation activities as required.

Functions, Duties and Tasks :

Testing :

• Performing all Work in progress and Final Product batch release tests within the scope of the Outlines of Production, according to Good Manufacturing Practices principles.

• Methods include, but are not limited to microbiology, cell culture, and molecular biology techniques.

• Performing Enviromental Monitoring tests and utilities testing for all departments.

• Performing Stability testing.

• Assisting in validation work as required.

• Equipment validations.

• Method validations.

• Update / maintain / create relevant Standard Operating Procedures, Source of supplies, Manufacturing Defect Forms and forms.

Quality Control Department Support:

• Recognize and report any Out of Scope or deviations to Quality Control Manager.

• Initiate and complete investigations where applicable.

• Interactions with production departments to ensure results are communicated.

• Occasional after-hours work, and on-call schedule.

• Ability to work within all Quality systems (including Trackwise, Regulus, Sharepoint).

• Cleaning duties.

• Maintaining inventory of reagents and expiry checks of materials.

• A dditional duties as required.

Education Minimum Requirement:

• A 2 year-year college diploma in science related discipline.

Required Experience and Skills:

• One or more years of experience working in a Good Manufacturing Practices/International Organization of Standardization environment.

• Proficient oral and written communication skills.

• Able to follow/comply with Manufacturing Directions, Standard Operating Procedures, Company/Corporate/Regulatory Policies.

• Ability to demonstrates basic skills in effective time management to meet given deadlines.

• Able to work effectively with team members and show initiative to support others on the team when needed.

• Proficient computer skills including MS Word and MS Excel.

Preferred Education, Experience and Skills:

• A Bachelor’s degree in a Science related discipline

• Experience with one or more of the following areas: Molecular Biology, Microbiology (Bacterial), Microbiology (Viral)

• Experience performing investigations and assisting in deviations.

• A good understanding of aseptic processes.

• Experience using quality improvement tools and continuous improvement processes and site quality metrics.

• Advanced mathematical skills preferred.

Other Requirements and Information:

• Must be able to work a flexible schedule, including evenings, weekends, and overtime as required.

• Required to assist in disinfection procedures involving hazardous chemicals requiring the use of a respirator.

• Must be able to move and maneuver small-medium sized equipment.

• Requires ability to stand for long periods of time.

• Must be able to read, write, understand, and comply with appropriate standard operating procedures.

• All candidates are required to have adequate and legal work authorisation to work in Canada, prior to applying for posted positions.
  

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

The Company is required to provide a reasonable estimate of the salary range for this job in certain provinces within Canada. Final determinations with respect to salary will consider a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected CAD salary range: $45,100 - $76,700. Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, and vacation.

All candidates are required to have adequate and legal work authorization to work in Canada, prior to applying for posted positions. Only candidates with valid work authorization, not requiring company sponsorship in the course of their employment with our company will be considered in the recruitment process.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

L' assistant II - Analyste en contrôle de la qualité est responsable de réaliser les tests en cours de traitement (WIP) de tous les antigènes, et les tests de libération par lot conformément aux Schémas de production approuvés et aux Bonnes pratiques de fabrication. De plus, le technicien en contrôle de la qualité est chargé des tests de stabilité, des tests environnementaux et utilitaires, ainsi que des activités de qualification/validation selon les besoins.

Fonctions, tâches, missions:

• Réaliser tous les tests en cours de traitement (WIP) et de libération des produits finis dans le cadre des Schémas de production, selon les principes des Bonnes pratiques de fabrication.

• Les méthodes comprennent, sans s'y limiter, des techniques de microbiologie, de culture cellulaire et de biologie moléculaire.

• Réaliser les tests de suivis environnementaux et les tests utilitaires pour tous les départements.

• Réaliser les tests de stabilité. Participer aux travaux de validation selon les besoins. Validations d'équipement.

• Validations de méthode.

• Mise à jour, maintenance, création de Procédures opératoires normalisées et formulaires pertinents.

Soutien Contrôle de la Qualité

• Reconnaître et signaler tout résultat hors spécifications (OOS) ou toute déviation au responsable Assurance Qualité.

• Initier et mener à bien les investigations si nécessaire. Interactions avec les départements de production pour assurer la communication des résultats.

• Travail occasionnel en dehors des heures de travail et horaires de permanence.

• Capacité à travailler dans tous les systèmes de qualité.

• Tâches de nettoyage. Maintien de l'inventaire des réactifs et vérification des dates de péremption des matériaux.

• Autres tâches selon les besoins.

Éducation Minimale exigée:

• Un diplôme collégial de 2 ans dans une discipline scientifique.

Expérience et compétences requises :

• Un an ou plus d'expérience de travail dans un environnement de Bonnes pratiques de fabrications/ et les normes International Organization for Standardization.
• Compétences en communication orale et écrite.
• Capable de suivre/se conformer aux directives de fabrication, aux procédures opérationnelles standard, aux politiques de l'entreprise/corporatives/réglementaires.
• Capacité à démontrer des compétences de base en gestion efficace du temps pour respecter les délais donnés.
• Capable de travailler efficacement avec les membres de l'équipe et de montrer de l'initiative pour soutenir les autres membres de l'équipe lorsque nécessaire.
• Compétences informatiques incluant MS Word et MS Excel.

Éducation, expérience et compétences préférées :

• Un baccalauréat dans une discipline scientifique
• Expérience dans un ou plusieurs des domaines suivants : biologie moléculaire, microbiologie (bactérienne), microbiologie (virale)
• Expérience dans la réalisation d'enquêtes et l'assistance dans les déviations.
• Une bonne compréhension des processus aseptiques.
• Expérience dans l'utilisation d'outils d'amélioration de la qualité et de processus d'amélioration continue et des métriques de qualité du site.
• Avancé compétences mathématiques préférées.

Autres exigences et informations :

• Doit être capable de travailler selon un horaire flexible, y compris le soir, les week-ends et les heures supplémentaires si nécessaire.
• Nécessaire pour aider dans les procédures de désinfection impliquant des produits chimiques dangereux nécessitant l'utilisation d'un respirateur.
• Doit être capable de déplacer et de manœuvrer des équipements de petite à moyenne taille.
• Nécessite la capacité de rester debout pendant de longues périodes.
• Doit être capable de lire, écrire, comprendre et se conformer aux procédures opérationnelles standard appropriées.

• Tous les candidats doivent avoir une autorisation de travail adéquate et légale pour travailler au Canada, avant de postuler pour les postes affichés.
  

Nous sommes fiers d'être une entreprise qui embrasse la valeur de rassembler des personnes diversifiées, talentueuses et engagées. La façon la plus rapide d’innover est de rassembler des gens de diverses opinions dans un environnement inclusif. Nous encourageons nos collègues à remettre en question avec respect les problèmes de réflexion et d’approche de l’un et de l’autre. Nous sommes un employeur souscrivant au principe de l’égalité d’accès à l’emploi et nous sommes déterminés à favoriser un milieu de travail inclusif et diversifié.

L’entreprise doit fournir une estimation raisonnable de la fourchette de salaire pour ce poste dans certaines provinces du Canada. Les déterminations finales concernant le salaire prendront en compte un certain nombre de facteurs, qui peuvent inclure, mais sans s'y limiter, le lieu de travail principal et les compétences pertinentes, l'expérience et l'éducation du candidat choisi. Fourchette de salaire attendue en CAD: $45,100 - $76,700. Les avantages disponibles comprennent l'éligibilité aux primes, des incitations à long terme le cas échéant, des avantages en matière de soins de santé et d'autres assurances (pour l'employé et sa famille), des prestations de retraite, des congés payés et des vacances.

Tous les candidats doivent avoir une autorisation de travail adéquate et légale pour travailler au Canada, avant de postuler les postes affichés.

Seuls les candidats disposant d'une autorisation de travail valide, ne nécessitant pas de parrainage de l'entreprise pendant leur emploi dans notre organisation, seront pris en compte dans le processus de recrutement.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

yes

Required Skills:

Analytical Problem Solving, Cell-Based Assays, Cell Cultures, Environmental Testing, GMP Compliance, Good Laboratory Practices (GLPs), Microbiological Cultures, Molecular Biology, Molecular Microbiology, Problem Solving, Quality Control Processes, Quality Standards, Software Systems, Time Management

Preferred Skills:

Equipment Validations, Good Manufacturing Practices (GMP), Microbiology, Molecular Biology Lab, Quality Control (QC)

Job Posting End Date:

06/7/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

About the company

Merck & Co., Inc.

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