Sterility Assurance Specialist

2 weeks ago

Newbury, United Kingdom BAXTER Full time

**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.

**Summary**:
We are currently looking for an experienced Sterility Assurance Specialist, initially on an 18 Month fixed term contract.

The Sterility Assurance specialist will provide technical expertise and support to the UK Compounding Sites for all sterility assurance aspects. He/she will act as a valuable and effective source of information and advice on sterility assurance and will positively contribute to the network Quality Management Team. He/she will be responsible for ensuring that the UK Compounding Sites maintain a robust, effective and compliant sterility assurance and environmental control and monitoring process in conjunction with the global strategy

***Essential duties and Responsibilities**:

- Responsible for ensuring effective sterility assurance and environmental monitoring programmes are deployed in UK Compounding facilities in compliance with current GMP and the Baxter global strategy.
- Supporting the Global compounding organization on standardization of sterility assurance practices and identification/implementation of new technology for microbiological testing and environmental control.
- Participation in continuous improvement projects and providing the expert guidance and assessment for the questions related with Sterility insurance, including risk reduction initiatives in line with company strategy
- Support and lead problem solving investigations for product and process deviations or customer complaints
- Provide coaching and mentoring to other functions in problem solving with respect to Sterility Assurance
- Participate in UK Compounding complaints investigation, Nonconformance and quality incidents investigation, act as technical approver.
- Provide technical support in interpretation of Microbial Identification and Environmental Monitoring data and for the trending of EM and Microbiological data including setting of appropriate Alert limits
- Support Environmental Monitoring Management Software approval and reporting.
- Responsible for the Tracking and Reporting or Quality Metrics for internal and external use.
- Support the development of the quality documentation including local SOP’s, approval of documents related with Sterility Assurance as Technical Approver.
- Providing Microbiological expertise for operational and quality staff including periodic reassessment

**Education and Experience**:

- Degree in Microbiology (although others may be considered with relevant experience)
- Experience in implementing environmental control programs and OOL investigation and correction
- Experience of microbiology experience in an aseptic facility
- Must have strong operational experience preferably in an aseptic manufacturing background
- Experience of aseptic technique-Have excellent interpersonal skills
- Be a passionate advocate of quality as a discipline and continuous improvement
- Have experience in the use of quality improvement and problem-solving skills (ie FMEA, DMAIC, Process Mapping etc) and the interpretation of data, experience of Lean manufacturing
- Have experience of critical equipment and process Change Control
- Able to work autonomously and take the initiative

**What are some of the benefits of working at Baxter?**:

- Competitive salary and benefits
- Professional development opportunities
- High importance placed on work life balance
- Commitment to growing and developing an inclusive and diverse workforce

IND-UKOPS

IND-UKCOM

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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