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GMP Quality Assurance Auditor

3 months ago

Harrogate, United Kingdom HAR Labcorp Early Development Laboratories Limited Full time

Do you have GMP operational or biologics experience in industry?

Are you passionate about quality assurance and looking to work in a supportive and stable team?

Do you want a role with a structured career development path?

If so, read on

Recognized as one of Forbes’ World’s Best Employers and named one of The World’s Most Admired Companies 2024 by Fortune, here at Labcorp, we strive to make a difference to people’s everyday lives by bringing essential products to the market. As a GMP Quality Assurance Auditor at Labcorp based at our site in Harrogate, North Yorkshire,  you will play a critical role in making this happen.

The GMP Quality Assurance Auditor is responsible for supporting the local implementation and operation of the GMP Quality Management System. The role aims to ensure the site remains in a state of GMP compliance by participation in audits, data reviews, investigations, validation projects and the delivery of GMP related training, etc.

Responsibilities Include:

Participating on quality issue resolutions and quality / efficiency improvement initiatives to help assess impact, investigate root cause and plan and execute proposed actions

Monitoring, compiling and reporting on appropriate quality metrics and data trends related to the local performance of the quality management system for input into the Management Review Process; assess and report post-market surveillance data in accordance with regulatory requirements

Participating in the delivery of basic regulatory based training

Supporting the internal audit programme by participating in audits of systems, processes and facilities

Study Specific Oversight: a. Pharmaceutical GMP Studies: Providing regulatory review of study related documentation (i.e. methods, protocols, reports, certificates of analysis, etc.) prior to approval by senior GMP QA personnel.b. CDx Studies: Creating quality plans that support the development of Medical Device and/or IVD products

Supporting validation and verification activities, including but not limited to protocol development and execution and deviation / non-conformance resolution; review of key validation deliverables

Reviewing of metrology methods and specifications for accuracy / relevance and compliance with appropriate quality standards

Maintaining processes to support document and configuration control requirements (CDx only)

Reviewing and approving site-based controlled documents (SOPs, Policies, etc.) to ensure compliance with applicable regulations, Labcorp document management procedures and other relevant quality standards

Ensuring Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed

What Labcorp Offers:

Competitive salary and benefits package including health cover and contributory pension

Considerable interaction with internal and external stakeholders including clients and regulatory bodies

Opportunity to develop and grow your career whilst making a difference to people’s everyday lives

A culture of CARE with access to well-being programs and various employee resource groups

Flexible and hybrid work once the training has been completed

Excellent relocation package (subject to criteria)

  Education:

A minimum of a Bachelors Degree in a Chemistry or Biology related discipline

Postgraduate degree (MSc or equivalent) in science or management related discipline, preferable

Skills / Experience:

Demonstrable experience of GMP auditing/laboratory work in a drug development/pharmaceutical setting

In depth knowledge of Good Manufacturing Practice Regulations

General awareness of industry quality systems / standards, e.g. ICHQ10

Good communication, decision making, negotiating, and problem solving skills

Experience in process improvement

Customer service orientated, i.e. ability to interact effectively with clients

Ability to work under minimal supervision

Strong verbal and written communication skills

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all to apply

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