Gmp Operator 1

3 weeks ago

Keele, United Kingdom Charles River Laboratories Full time

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

**Job Summary**:
We are currently looking for an experienced GMP Operator to support the growth of our Product Delivery team.

**Profile and Requirements**:
**The Role**
- Working within a GMP production environment the role will include:
- To form part of multidisciplinary teams in a cleanroom production environment
- To support and maintain the status of the GMP production facility clean rooms.
- Compliant execution of GMP processes according to Batch Manufacturing Records.
- Ensure production logbooks and Batch Manufacturing Records are completed and maintained according to Standard Operating Procedures.
- Prepare, review and revise production documentation (eg Standard Operating Procedures, Material Specification Sheets)
- Use of standard clean room equipment including, peristaltic pumps, balances, pH meters and biowelders/sealers
- Escalation and reporting of non-conformance events

**About You**

You must be flexible in your approach to work and willing to work additional hours to accommodate processing.

In addition, you will be fully conversant with Microsoft Office; the enthusiasm to learn and the ability to interact and communicate effectively with colleagues at all levels within the organisation are also essential.

This role will be based at Keele, Staffordshire, however, a willingness to travel within the Group will be required.

**About Biologics Testing Solutions**
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterzation, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

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