GMP Compliance Quality Auditor

4 weeks ago

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

Are you experienced in GMP operations or biologics within the industry?

Do you have a strong commitment to quality assurance and seek a collaborative and stable work environment?

Are you interested in a position that offers a clear path for career advancement?

If this resonates with you, continue reading.

At Labcorp, recognized as one of Forbes' World's Best Employers and honored as one of The World's Most Admired Companies 2024 by Fortune, we are dedicated to enhancing people's lives by delivering essential products to the market. As a GMP Quality Assurance Auditor at Labcorp, you will be integral to our mission.

The GMP Quality Assurance Auditor plays a vital role in the local execution and management of the GMP Quality Management System. This position is focused on ensuring the site maintains compliance with GMP standards through participation in audits, data evaluations, investigations, validation initiatives, and the provision of GMP-related training.

Key Responsibilities Include:

Engaging in quality issue resolutions and initiatives aimed at enhancing quality and efficiency, including assessing impacts, investigating root causes, and planning and executing corrective actions. Monitoring, compiling, and reporting relevant quality metrics and data trends related to the local performance of the quality management system for inclusion in the Management Review Process; evaluating and reporting post-market surveillance data in line with regulatory standards. Assisting in the delivery of foundational regulatory training. Supporting the internal audit program by participating in audits of systems, processes, and facilities. Study Specific Oversight: a. Pharmaceutical GMP Studies: Conducting regulatory reviews of study-related documentation (e.g., methods, protocols, reports, certificates of analysis) prior to approval by senior GMP QA personnel. b. CDx Studies: Developing quality plans that facilitate the advancement of Medical Device and/or IVD products. Aiding in validation and verification activities, including protocol development and execution, as well as deviation/non-conformance resolution; reviewing key validation deliverables. Evaluating metrology methods and specifications for accuracy, relevance, and compliance with applicable quality standards. Maintaining processes to support document and configuration control requirements (specific to CDx). Reviewing and approving site-based controlled documents (SOPs, Policies, etc.) to ensure adherence to applicable regulations, Labcorp document management procedures, and other relevant quality standards. Ensuring compliance with Regulatory Compliance and Quality Assurance (RC&QA) responsibilities as outlined in relevant controlled documents.

What Labcorp Provides:

Competitive salary and comprehensive benefits package, including health coverage and a contributory pension plan. Significant interaction with internal and external stakeholders, including clients and regulatory authorities. Opportunities for professional development and growth while making a meaningful impact on people's lives. A culture of CARE with access to well-being programs and various employee resource groups. Flexible and hybrid work arrangements following the completion of training. Attractive relocation package (subject to criteria).

Education Requirements:

A minimum of a Bachelor's Degree in a Chemistry or Biology-related field. A postgraduate degree (MSc or equivalent) in a science or management-related discipline is preferred.

Skills and Experience:

Proven experience in GMP auditing or laboratory work within a drug development or pharmaceutical environment. In-depth knowledge of Good Manufacturing Practice Regulations. General awareness of industry quality systems and standards, such as ICHQ10. Strong communication, decision-making, negotiation, and problem-solving skills. Experience in process improvement initiatives. Customer service-oriented, with the ability to interact effectively with clients. Ability to work independently with minimal supervision. Excellent verbal and written communication skills.

Labcorp is committed to being an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp values diversity and inclusion in the workforce and does not tolerate any form of harassment or discrimination. Employment decisions are made based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender (including pregnancy or other medical conditions), family or parental status, marital status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all qualified individuals to apply.

If you are an individual with a disability requiring assistance with our online tools to search and apply for jobs, please reach out for support.

For more information on how we collect and store your personal data, please refer to our privacy policy.

  • GMP Compliance Quality Auditor

    4 weeks ago

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

    Are you experienced in GMP operations or biologics within the industry? Do you have a strong commitment to quality assurance and seek a collaborative and stable work environment? Would you like to pursue a career with a clear development trajectory? If this resonates with you, continue reading. At Labcorp, recognized as one of Forbes' World's...

  • GMP Compliance Auditor

    4 weeks ago

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

    Are you experienced in GMP operations or biologics within the industry? Do you have a strong commitment to quality assurance and seek a role within a supportive and stable environment? Are you interested in a position that offers a clear path for career advancement? If this resonates with you, continue reading. Recognized as one of the leading...

  • GMP Quality Assurance Auditor

    4 weeks ago

    Harrogate, North Yorkshire, United Kingdom Labcorp 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 onRecognized as one of Forbes' World's Best Employers and named one of The World's Most Admired Companies 2024 by Fortune, here...

  • GMP Quality Assurance Auditor

    3 weeks ago

    Harrogate, North Yorkshire, United Kingdom Labcorp 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 onRecognized as one of Forbes' World's Best Employers and named one of The World's Most Admired Companies 2024 by Fortune, here...

  • Regulatory Auditor

    5 days ago

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

    About the RoleWe are seeking a highly skilled GMP Quality Assurance Auditor to join our team at HAR Labcorp Early Development Laboratories Limited. As a key member of our quality assurance team, you will play a critical role in ensuring the site remains in a state of GMP compliance.Key ResponsibilitiesParticipate in quality issue resolutions and...

  • Regulatory Auditor

    6 days ago

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

    About the RoleWe are seeking a highly skilled GMP Quality Assurance Auditor to join our team at HAR Labcorp Early Development Laboratories Limited. As a key member of our quality assurance team, you will play a critical role in ensuring the site remains in a state of GMP compliance.Key ResponsibilitiesParticipate in quality issue resolutions and...

  • Auditor - Financial Services

    3 days ago

    Harrogate, North Yorkshire, United Kingdom IPS Group Full time

    Job Summary:We are seeking a highly skilled and motivated Auditor to join our team at IPS Group. As an Auditor, you will play a critical role in ensuring the accuracy and reliability of financial information for our clients.Key Responsibilities:Conduct audits of financial statements and other financial data to ensure accuracy and compliance with regulatory...

  • Auditor - Financial Services

    3 days ago

    Harrogate, North Yorkshire, United Kingdom IPS Group Full time

    Job Summary:We are seeking a highly skilled and motivated Auditor to join our team at IPS Group. As an Auditor, you will play a critical role in ensuring the accuracy and reliability of financial information for our clients.Key Responsibilities:Conduct audits of financial statements and other financial data to ensure accuracy and compliance with regulatory...

  • Compliance Specialist

    6 days ago

    Harrogate, North Yorkshire, United Kingdom Eric Wright Group Full time

    About the RoleWe are seeking a highly skilled and experienced Internal Auditor to join our team at the Eric Wright Group. As a key member of our compliance team, you will play a critical role in ensuring the effective implementation of our internal controls and risk management processes.Key ResponsibilitiesDevelop and implement internal audit plans to ensure...

  • Compliance Specialist

    5 days ago

    Harrogate, North Yorkshire, United Kingdom Eric Wright Group Full time

    About the RoleWe are seeking a highly skilled and experienced Internal Auditor to join our team at the Eric Wright Group. As a key member of our compliance team, you will play a critical role in ensuring the effective implementation of our internal controls and risk management processes.Key ResponsibilitiesDevelop and implement internal audit plans to ensure...

  • Internal Auditor

    5 days ago

    Harrogate, North Yorkshire, United Kingdom Eric Wright Group Full time

    About the RoleWe are seeking a highly skilled and experienced Internal Auditor to join our team at the Eric Wright Group. As a key member of our compliance team, you will play a crucial role in ensuring the effective implementation of our internal controls and risk management processes.Key ResponsibilitiesDevelop and implement the annual audit plan, ensuring...

  • Internal Auditor

    6 days ago

    Harrogate, North Yorkshire, United Kingdom Eric Wright Group Full time

    About the RoleWe are seeking a highly skilled and experienced Internal Auditor to join our team at the Eric Wright Group. As a key member of our compliance team, you will play a crucial role in ensuring the effective implementation of our internal controls and risk management processes.Key ResponsibilitiesDevelop and implement the annual audit plan, ensuring...

  • Auditor - Financial Services Expert

    7 days ago

    Harrogate, North Yorkshire, United Kingdom IPS Group Full time

    Job Summary:We are seeking a highly skilled Auditor to join our team at IPS Group. As an Auditor, you will play a critical role in ensuring the accuracy and integrity of our clients' financial statements.Key Responsibilities:Conduct thorough audits of financial statements, identifying areas of risk and recommending improvements.Develop and implement audit...

  • Financial Auditor

    6 days ago

    Harrogate, North Yorkshire, United Kingdom IPS Group Full time

    Job Summary:We are seeking a highly skilled and motivated Auditor to join our team at IPS Group. As an Auditor, you will play a critical role in ensuring the accuracy and reliability of financial information for our clients.Key Responsibilities:Conduct audits of financial statements and other financial data to ensure compliance with relevant laws and...

  • Financial Analyst

    7 days ago

    Harrogate, North Yorkshire, United Kingdom IPS Group Full time

    Job Summary:We are seeking a highly skilled Auditor to join our team at IPS Group. As an Auditor, you will play a critical role in ensuring the accuracy and integrity of our clients' financial statements.Key Responsibilities:Conduct thorough audits of financial statements, identifying areas of risk and recommending improvements.Develop and implement audit...

  • Senior Accountant/Auditor

    7 days ago

    Harrogate, North Yorkshire, United Kingdom Pratap Partnership Ltd Full time

    Company OverviewPratap Partnership Ltd is a leading accountancy practice that has achieved significant success through its commitment to excellence and innovation. Our firm prioritizes the growth and development of our professionals, providing them with opportunities to excel in their careers and contribute to the success of our clients.Job SummaryWe are...

  • Financial Analyst

    7 days ago

    Harrogate, North Yorkshire, United Kingdom IPS Group Full time

    Job Summary:We are seeking a highly skilled Auditor to join our team at IPS Group. As an Auditor, you will play a critical role in ensuring the accuracy and integrity of our clients' financial statements.Key Responsibilities:Conduct thorough audits of financial statements, identifying areas of risk and recommending improvements.Develop and implement audit...

  • Senior Accountant/Auditor

    7 days ago

    Harrogate, North Yorkshire, United Kingdom Pratap Partnership Ltd Full time

    **About Pratap Partnership Ltd**We are a leading accountancy practice with a strong reputation for delivering high-quality services to our clients. Our team is passionate about providing exceptional support and guidance to businesses in the region.**Job Summary**We are seeking a highly skilled Senior Accountant/Auditor to join our team. As a key member of...

  • Water Safety Auditor

    5 days ago

    Harrogate, North Yorkshire, United Kingdom Harrogate Integrated Facilities Full time

    About the RoleThe Water Flushing Compliance Officer will play a crucial role in ensuring the highest achievable level of domestic compliance with the Trust's guidelines on the control of Legionella, Pseudomonas, and other opportunistic pathogens.Key ResponsibilitiesSupport the Hotel & Site Services Manager in providing assurance by undertaking regular audits...

  • Water Safety Auditor

    7 days ago

    Harrogate, North Yorkshire, United Kingdom Harrogate Integrated Facilities Full time

    About the RoleThe Water Flushing Compliance Officer will play a crucial role in ensuring the highest achievable level of domestic compliance with the Trust's guidelines on the control of Legionella, Pseudomonas, and other opportunistic pathogens.Key ResponsibilitiesSupport the Hotel & Site Services Manager in providing assurance by undertaking regular audits...