Senior Quality Control Analyst Temporary role

WuXi AppTec
CH - Nebraska - / /CH
December 31, 2024

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.

Read the full job description and apply online on the recuiter's web-site

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