Quality Assurance Officer - Keele, United Kingdom - Charles River Laboratories, Inc.

Description

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

Our Keele site is looking to recruit an Operational Quality Assurance Officer on a permanent, full time basis. The ideal candidate will have experience of working in a Quality role, to GMP standards but this not essential as full comprehensive training will be provided to the successful candidate. This role will be office based but you will work closely with the lab based teams to ensure standards are adhered to in line with industry standards.

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.

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

Profile and Requirements

• Ideally Science degree or equivalent, with proven relevant experience in a pharmaceutical Manufacturing or Quality Assurance role.

• You will have good working knowledge of GMP, ideally in the pharmaceutical sector but this is not essential - full training will be provided.

• Or, minimum A Level qualifications in Science with 2 years experience in an operational Quality Assurance role working to GMP standards.

This role will be based at Keele, Staffordshire. Therefore, candidates must be able to travel to this site on a daily basis.

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.

With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

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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