Quality Assurance Officer

3 weeks ago

Keele, United Kingdom Charles River Laboratories Full time

**Req ID**:222334**Location**:Keele, GB, ST5 5SP- At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families.
- Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career.
- As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.

**Job Summary**
-As part of the role you will need to have excellent attention to detail, have a pro active approach to problem solving, be able to effectively communicate, both verbally and in writing. The role will require you to be able to manage priorities whilst working both as part of a team and independently in a fast paced environment.

**Profile and Requirements**
The main duties will include:

- Provide ‘in suite’ operational QA oversight and assistance on quality related issues within the GMP manufacturing Grade D and Grade C Facility.
- Provide Facility Systems support, including review and approval of HVAC Pressures, Temperature, and Cleaning Logs,
- Perform ‘in suite’ Room Inspections and Release.
- Issue, review and approval of GMP batch manufacturing records to support QP certification and release.
- Assist in performance of internal self-inspection audits
- Generation, review and approval of relevant quality documentation
- Support with assessment of deviation event investigations
- Support closure to plan of Change Controls and CAPA actions.
- Assist and lead continuous improvement projects
- Review and approval of Validation reports.
- Archiving of operational and quality control documentation
Education / Experience:

Ideally Science degree or equivalent, with proven relevant experience in a pharmaceutical Manufacturing or Quality Assurance role.
Minimum requirement science related A level with 2 years experience in an operational Quality Assurance role. You will have good working knowledge of GMP, ideally in the pharmaceutical sector but this is not essential.
This role will be based at Keele, Staffordshire.

**About Corporate Functions**
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
- **About Charles River**
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.- At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.

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