As a Sr QC Analyst, with a CDMO organization, 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.

Essential Job Functions:

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

• Performs analytical testing according to raw material and product release specifications (HPLC, GC, UV/VIS, IR, dissolution, pH, conductivity, TOC, titration, weighing, wet chemistry experiments etc.).
• Performs review of analytical data.
• Writes and reviews all types of GMP documents (e.g. test method, SOP, WPR, validation protocols and reports, investigation reports etc.
• Handles deviations and OOS in the applicable software tool
• Handles change control in the applicable software tool
• Supports internal and external audits
• Takes responsibility in method transfer and method validation activities.
• Takes responsibility in selection, purchase and commissioning of new equipment.
• QC representative in transversal project.
• In charge of the support of QC team members (“center of competencies”)

Job Requirements:

This role might be for you if:

• You have current experience of minimum seven years multifunction testing in the following QC testing sectors as

• • Chemistry,
  • AS&T,
  • Microbiology,
  • Stability,

• You have a deeply working knowledge with HPLC/UPLC in a regulated environment – MUST HAVE
• You have a proven ability to work independently or as part of a team. - MUST HAVE
• You possess strong troubleshooting and problem-solving skills. - MUST HAVE
• You are force of proposition with concrete and reflected solutions. - MUST HAVE
• You have strong attention to detail & excellent written and oral skills. - MUST HAVE
• You possess deep ethical and commitment values. - MUST HAVE
• You speak fluent English (C1); French is a big plus. - MUST HAVE
• And very important, you understand and have practice on Lean project management and linked planning and reporting tools. - MUST HAVE
• 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 - MUST HAVE
• You are living “closer” to the Neuchatel region, or within a maximum of 1,5 hours commuting by car or train or can relocate to this amazing region. The site offers a wonderful natural environment. A private car is highly recommended.

Objectives

Within the first 2 weeks, you will...

• Gain a comprehensive understanding of WuXiApptec Quality Control, Quality assurance and EHS processes and standards, specifically focusing on the nuances of the site testing functions as well as a comprehensive use of all site IT systems linked to the quality control department.

From the third week...

• You’ll gain practice in the laboratory. This includes familiarization with testing procedures for samples, raw materials, drug substances, and drug products. You’ll be accompanying colleagues through each of the laboratory department: AS&T, Chemical, Microbiology, Stability and Packaging. You’ll also start to Implement Lean methodologies within the Quality Control department.

From the fourth week...

• You’ll be ready to be involved in the current planning, analysing under current processes, identifying areas for efficiency improvements, and suggesting changes that could enhance the overall productivity and effectiveness of testing functions.

Experience / Education

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.