Lonza
pharmaceutical, biotechnology
QCTechnicalExpert
Neural analysis suggests this role is
optimal for Senior candidates.
“QC Technical Expert at Lonza. Skills: LC-MS, HPLC, Analytical Method Validation. Apply scientific skills. Provide advice”
What You'll Achieve.
Contribute to quality of therapies; Contribute to safety of therapies
Industry & Context.
Risk analysis
12 Month Fixed Term Contract
What They're Looking For.
Must Have
5+ years in QC laboratory or related role within the pharmaceutical, biotechnology, or similar industry, Extensive practical and technical knowledge of LC-MS and HPLC based methods and other laboratory techniques (e. g. , ELISA, UV Spec), Subject Matter Expert in QC LC-MS, HPLC, Extensive experience in Analytical Method Validation
Nice to Have
Effective trainer and imparts regular trainings to QC team members
What You'll Do.
Apply scientific skills
Participate in gap assessment
Transfer new QC methods
Validate new QC methods
Implement new QC methods
Write quality documents
Review quality documents
Approval of quality documents
Draft method validation protocols
Review method validation protocols
Participate in method validation
Generate QC documents
How You'll Work.
Team & Collaboration
Act as representative of QC department; Close collaboration with manufacturing; Collaboration during team meetings; Collaboration during Quality Councils; Collaboration during client meetings
Full Job Description
**Job Title: QC Technical Expert Location: Geleen 12 Month Fixed Term Contract** We are looking for a **_QC Technical Expert_** to join our company and you will be required to apply scientific skills, knowledge and experience to provide advice and propose improvements where required. The position needs to thoroughly understand the activities linked to the applicable expertise, risk analysis, method implementation and other QC related issues in branch. **What you will get** * A varied laboratory role with the opportunity to grow skills across several QC disciplines. * Hands-on experience with a wide range of assays, techniques and GMP processes. * A supportive team environment with training, coaching and clear development pathways. * The chance to contribute directly to the quality and safety of life-changing therapies. **What you will do** * Act as a representative of the QC department for Quality Control topics, with close collaboration with manufacturing during team meetings, Quality Councils, client meetings if applicable. * Apply scientific skills, knowledge and experience to provide advice and propose improvements where required. * Participates in the gap assessment, transfer, validation and implementation of new QC methods and equipment. * Write, review, and approval of quality documents (SOPs, stability protocols, reports, and quality instructions). * Draft and review method validation protocols and reports in line with regulatory guidelines. Participate in execution of method validation activities. * Generate, review and approve QC documents and acts as expert for QC during internal and external audits and inspections. **What we are looking for** * Hands on experience (5+ years) in QC laboratory or related role within the pharmaceutical, biotechnology, or similar industry. * Extensive practical and technical knowledge of LC-MS and HPLC based methods and other laboratory techniques (e.g., ELISA, UV Spec) * Subject Matter Expert in QC assays; LC-MS, HPLC * Eff
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