QC Raw Materials & Compendial Scientist - GMP Focus

WuXi Biologics; Leinster; On-site; EUR 45,000 - 65,000; Full time

Job summary

WuXi Biologics is seeking a QC Raw Materials and Compendial Associate Scientist to perform quality control testing of received raw materials and support GMP, GLP and regulatory compliance in our fast-paced QC lab. You will work on methods like HPLC, GC and compendial testing, contribute to method validation, lab setup, equipment qualification, audits, and ongoing KPI monitoring, reporting to the Team Lead.

University degree required; strong communication, attention to detail, teamwork and

Qualifications

• Experience in working as part of a team and also as an individual contributor.
• Strong communication skills.
• Excellent attention to detail.
• Performing work assignments accurately, timely and in a safe manner.
• Previous experience in a Quality Control/GMP environment is an advantage.
• Knowledge of analytical testing in support of biopharmaceutical manufacturing is preferred but not required.

Responsibilities

• To perform Quality Control testing of received raw materials to support the manufacturing process.
• Experience in using and troubleshooting a wide range of testing techniques including but not limited to HPLC, GC and Compendial testing techniques.
• Ensure the tasks associated with the startup and routine operations of a QC Raw Materials and Compendial laboratory are carried out in a safe manner.
• Support QC lab set-up, including laboratory design, equipment installation and qualification utilizing principles of Operational Excellence and Lean Labs.
• Support facility qualification.
• Support and lead QC test method validation and development of routine testing strategies when required.
• Perform additional duties at the request of the direct manager, supervisor or designee.
• Routine monitoring of laboratory KPI’s, stock control of laboratory consumables and reagents and support for future expansion/upgrade projects.
• Support QC Senior scientist in OOS, OOL, adverse trends, any excursion investigations, change controls, and CAPAs tasks.
• Participate in relevant internal and external QC related audits.
• Ability to work in a team environment and independently as required.
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics Policies and Standard Operating Procedures.
• Thorough understanding of current Good Manufacturing Practices.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
• Flexibility to take on additional tasks and responsibilities at the discretion of the QC Raw Materials and Compendial Senior Scientist
• Will act as a role model for the QC function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Skills

Strong communication

Attention to detail

Team and independent work

Troubleshooting and problem-solving

Education

University degree in related science/quality discipline

Job description

WuXi Biologics is seeking a QC Raw Materials and Compendial Associate Scientist to perform quality control testing of received raw materials and support GMP, GLP and regulatory compliance in our fast-paced QC lab. You will work on methods like HPLC, GC and compendial testing, contribute to method validation, lab setup, equipment qualification, audits, and ongoing KPI monitoring, reporting to the Team Lead.

University degree required; strong communication, attention to detail, teamwork and