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Job Opportunity

Job Opportunity
QC Raw Material & Compendial Associate Scientist
QC Raw Material & Compendial Associate Scientist
Ireland     Posted 2023-12-15

QC Raw Materials and Compendial Associate Scientist 

 

As a QC 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.    

 

Organization Description

 

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.

 

Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, Asia and Israel. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.

 

Department Description

 

As a QC Raw Materials and Compendial Associate Scientist, you’ll be joining an organization 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 Senior Scientist.

 

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.

 

 

Your Profile

 

The ideal candidate for this position, will have the following:

 

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.

 

Onerous requirements

 

  • Shift work and business travel may be required for this position as directed by departmental management.

 

 

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.

 

Apply now!

 

Would you like to know more before you apply? Please visit us at https://www.wuxibiologics.com/join-us/ or contact us via talentacquisition@wuxibiologics.com

 

 WuXi Biologics is an equal opportunities employer.