Senior Quality Control Analyst

at  Caresilium

CARESILIUM est une société de conseils en ingénierie 100% suisse romand. Notre flexibilité, ainsi que les valeurs que nous portons : l’honnêteté, la franchise et la simplicité, nous permettent de créer des accompagnements sur mesures qui tiennent comptes de tous les besoins, les enjeux et les contraintes de nos partenaires. Une collaboration de confiance, c’est avant tout un recrutement bienveillant et transparent.
Avec CARESILIUM, rejoignez une équipe où vos attentes professionnelles ET personnelles sont au centre des décisions. Chaque parcours est accompagné individuellement par un manager technique qui saura vous guider vers votre but.
Et rappelez-vous toujours : chez CARESILIUM, notre plus belle valeur, c’est vous
Vous avez des questions ? Besoin de précision ? N’hésitez pas à prendre contact avec nous!

JOB DESCRIPTION

As a Sr QC Analyst, within a CDMO organisation, you will perform a wide variety of chemical or biological analyses on products, in-process materials, or samples in support of the company’s quality assurance and quality control program.

In this role a typical day might include, but is not limited to, the following:

• Conducting testing on in-process, product, stability, and/or research samples.
• Gathering data and documenting test results, completing test records and reviewing data.
• Reviewing test results to ensure compliance with GMP, GLP, GCP standards; reporting any quality anomalies.
• Complying with all applicable regulatory requirements.
• Participating in required training activities, digital, theory and practice.
• Maintaining laboratory supplies.
• Writing and revising control test procedures and SOPs and participate on continuous improving actions.
• Verifying calibration of instruments/devices prior to use.
• Interacting with outside customers or/and functional peer groups.
• May be responsible for maintaining a specific project, initially as backup.
• May devise or develop new analytical methods and techniques.
• May assist in validation and method transfer of methods.
• May be involved in establishing the transfer of methodology from customers.
• May follow CAPAs, change controls and deviations.

This role might be for you if:

• You have current experience of seven years multifunction testing in the following QC sectors within
• Chemistry,
• AS&T,
• Microbiology,
• Stability,
• Packaging.
• You have a deeply working knowledge with HPLC/UPLC in a regulated environment.
• You have a proven ability to work independently or as part of a team.
• You possess strong troubleshooting and problem-solving skills.
• You are force of proposition with concrete and reflected solutions.
• You have strong attention to detail & excellent written and oral skills.
• You possess deep ethical and commitment values.
• You speak fluent English (C1); French is a big plus.
• And very important, you understand and have practice on Lean project management and linked planning and reporting tools.
• You have a developed knowledge in quality assurance and quality control procedures.
• You have practice with Veeva Vault and Trackwise, LIMS, moreover with all the MS Office applications.
• You are originated from any EU Schengen country.
• You are living “closer” to the Neuchatel region, or within a maximum of 1,5 hours commuting by car or train, or can relocate. A private car is highly recommended.

PROFILE / REQUIREMENTS

To be considered for this role you should have a BS/BA in Life Sciences or related field. Minimum of 7 years’ experience in Pharma/Biotech/CDMO, quality control laboratory. HPLC/UPLC and Empower required. Experience in SE-UPLC, peptide and glycan assay desirable.
Does this sound like you

In this role a typical day might include, but is not limited to, the following:

• Conducting testing on in-process, product, stability, and/or research samples.
• Gathering data and documenting test results, completing test records and reviewing data.
• Reviewing test results to ensure compliance with GMP, GLP, GCP standards; reporting any quality anomalies.
• Complying with all applicable regulatory requirements.
• Participating in required training activities, digital, theory and practice.
• Maintaining laboratory supplies.
• Writing and revising control test procedures and SOPs and participate on continuous improving actions.
• Verifying calibration of instruments/devices prior to use.
• Interacting with outside customers or/and functional peer groups.
• May be responsible for maintaining a specific project, initially as backup.
• May devise or develop new analytical methods and techniques.
• May assist in validation and method transfer of methods.
• May be involved in establishing the transfer of methodology from customers.
• May follow CAPAs, change controls and deviations

This role might be for you if:

• You have current experience of seven years multifunction testing in the following QC sectors within
• Chemistry,
• AS&T,
• Microbiology,
• Stability,
• Packaging.
• You have a deeply working knowledge with HPLC/UPLC in a regulated environment.
• You have a proven ability to work independently or as part of a team.
• You possess strong troubleshooting and problem-solving skills.
• You are force of proposition with concrete and reflected solutions.
• You have strong attention to detail & excellent written and oral skills.
• You possess deep ethical and commitment values.
• You speak fluent English (C1); French is a big plus.
• And very important, you understand and have practice on Lean project management and linked planning and reporting tools.
• You have a developed knowledge in quality assurance and quality control procedures.
• You have practice with Veeva Vault and Trackwise, LIMS, moreover with all the MS Office applications.
• You are originated from any EU Schengen country.
• You are living “closer” to the Neuchatel region, or within a maximum of 1,5 hours commuting by car or train, or can relocate. A private car is highly recommended