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GMP Compliance Quality Auditor
2 months ago
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 Best Employers and honored as one of The World's Most Admired Companies 2024 by Fortune, we are dedicated to enhancing everyday lives by delivering essential products to the market. As a GMP Quality Assurance Auditor at Labcorp, you will be instrumental in achieving this mission.
The GMP Quality Assurance Auditor plays a vital role in facilitating the local execution and management of the GMP Quality Management System. This position is focused on ensuring that the site consistently meets GMP compliance standards through participation in audits, data evaluations, investigations, validation initiatives, and the provision of GMP-related training.
Key Responsibilities:
Engaging in quality issue resolutions and quality/efficiency enhancement projects to evaluate impact, investigate root causes, and develop and implement corrective actions. Monitoring, compiling, and reporting relevant quality metrics and data trends concerning the local performance of the quality management system for inclusion in the Management Review Process; assessing and reporting post-market surveillance data in line with regulatory obligations. Assisting in the delivery of fundamental 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. Assisting in validation and verification activities, including but not limited to protocol development and execution, and addressing deviations/non-conformances; reviewing key validation deliverables. Evaluating metrology methods and specifications for accuracy/relevance and adherence to applicable 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 relevant regulations, Labcorp document management procedures, and other pertinent quality standards. Ensuring that Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as outlined in applicable controlled documents, are adhered to.What Labcorp Provides:
Competitive salary and benefits package, including health coverage and a contributory pension. Significant interaction with internal and external stakeholders, including clients and regulatory authorities. Opportunities for professional development and career 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. Comprehensive 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/laboratory work within a drug development/pharmaceutical environment. Extensive knowledge of Good Manufacturing Practice Regulations. General awareness of industry quality systems/standards, such as ICHQ10. Strong communication, decision-making, negotiation, and problem-solving abilities. 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 harassment or discrimination of any kind. Employment decisions are made based on business needs and individual qualifications, without discrimination based on 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 qualified individuals to apply.
