Quality Assurance Associate/Releaser

at  Baxter

THIS IS WHERE YOU SAVE AND SUSTAIN LIVES

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Are you passionate about ensuring products are delivered to customers in the best quality possible? As a Quality Assurance Associate/Releaser you will take ownership for the reviewing and supervising completion of EM related tasks and completion of reviewing orders and releasing products. Accurately maintains technical data to control the production process. Provides technical skills and knowledge for all aspects of the units activities, including aseptic compounding, facility and equipment management and management of workflow in line with MHRA Manufacturing Licence and Quality System requirements.
Monday to Friday, 8am to 4pm or 10am to 6pm on rotation, with occasional requirements to work on 2pm to 10pm shift.

EDUCATION AND/OR EXPERIENCE

• Microbiology degree or equivalent experience required.
• Microbiology experience (preferable).
• Good understanding of the Regulatory requirements involving pharmaceutical manufacture. Specials licence requirements and compounding/aseptic process experience is desirable.
• Ability to communicate clearly and effectively in a timely manner with all members of the unit
• Ability to read, interpret and transcribe data accurately
• Customer orientated

• To undertake and successfully complete an in-house competency assessment programme for the release of manufactured products.
• Release of manufactured products according to defined procedures.
• Perform ‘in-process’ checks, and report any errors according to defined procedures.
• To work as an integral member of the quality team to deliver a timely, safe, quality aseptic manufacturing service to meet customer needs.
• To ensure that all documentation is complete and kept in a tidy and orderly manner
• To participate in the organisation and delivery of in-house education and training sessions.
• GEMBA pre audits carried out weekly in areas such as the clean-room, preparation room and label and release, to ensure SOP and GDP are followed correctly.
• Responsibility for ensuring all EM monitoring is carried out as per SOP.
• Responsible to lead EM activities with the QA Ops/QA Release team.
• To support QMS team with investigations related to EM activities.
• Ensure completion of EM reports for the site.