Laboratory Specialist

With a passion for life 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. 

Are you looking for an inspiring career? You just found it.

Job Description:

•            Executing analytical procedures in accordance with current approved specifications and GMP/cGMP’s and for maintaining the relevant SOP’s.

•            Perform analytical tests utilizing HPLC/UPLC, GC, UV, IR, FTIR and other laboratory instruments.

•            Ensuring accurate and on-time reporting

•            Assess, compare and perform risk assessments for compendial method compliance according to USP, EP, and other regulations.

•            Development, validation and verification of new methodologies, as part of GAP analysis or process improvement activities.

•            Act in accordance with policies, procedures, instructions, etc., established within the framework of the company's Quality and Environmental Management, and contribute to continuous improvement.

•            Investigate and perform lab related corrective and preventative actions (CAPA) testing and non-conformity (NC)’s

•            As a Laboratory Specialist perform, plan, and/or assist the necessary validations of test methods.

•            Develop protocols, reports, and methods in collaboration with other department teams.

•            Participate in internal and external audits.

•            Promote and maintain a safe and healthy working laboratory environment in compliance with established health and safety procedures.

Qualifications:

•            Graduated university with from departments of chemistry, biochemistry, chemical engineering.

•            Preferably, at least 3 years of experience in the Medical Device Industry or pharmaceutical Industry quality control processes

•            Proficient in English

•            Familiar with ISO 13485, European Medical Device Regulation, and FDA 21 CFR 820,USP,EP requirements; able to understand the regulatory environment.

•            Proficient in operating and In-depth understanding GC/HPLC/LC-MS/MS/GC-MS,uv-spectrophotometer, IR, FTIR.

•            Troubleshoot technical issues/ difficulties with methods.

•            Recognizes OOS or out-of-trend results and assists laboratory manager in the completion of lab investigations.

•            Proficient in Microsoft office programs (Outlook, Word, and Excel).

•            Preferably familiar with SAP, review technical data, documents, and proposals as required.

•            Preferably, Skills in statistical data analysis, documentation, and report writing in time manner.

•            Preferably, Hands-on experience with pharmaceutical data acquisition software e.g. Lab-solution, Empower and Open-lab, e-LIMS, Electronic Lab Notebook (ELN),ETQ etc.

•            Proficient and In-depth understanding USP, ICH, EP method validation, equipment qualification requirements

•            Able to participate in validation processes and open to self-improvement and learning in validation processes.

•            Analytical thinking with attention to detail

•            Team player with strong communication skills

•            Results-focused, open-minded, and eager to learn.

About us  

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.