QC Raw Materials & Compendial Associate Scientist

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

Job description:

As aQC Raw Materials and Compendial Associate Scientist,you’ll be responsible for carrying out tasks and supporting projects related to the QC testing and release of raw materials ensuring that the highest standards of GMP, GLP and Regulatory are strictly adhered to.

Department Description

As a QC Raw Materials and Compendial Associate Scientist, you’ll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.In this role, you’ll be reporting to the QC Raw Materials and Compendial Team Lead.

Your 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.

Technical Competencies

• Knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
• Familiarity with Pharmacopeia testing methods and requirements.

Experience

• 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

• Knowledge of analytical testing in support of biopharmaceutical manufacturing is preferred but not required.

Qualifications

• University degree in related science/quality discipline required.

Behavioural Competencies

• Excellent communication and interpersonal skills.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.
• Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
• Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers' expectations.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential!

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision -Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.

WuXi Biologics is an equal opportunities employer.