Current jobs related to Lead Quality/GxP Auditor - Durham - LS Solutions

  • Lead Validation Specialist

    6 days ago

    Durham, North Carolina, United States i-Pharm GxP Full time

    Job Title: Lead Validation ConsultantAbout the Role:We are seeking a highly experienced Lead Validation Consultant to join our team at i-Pharm GxP. As a key member of our team, you will be responsible for leading equipment and cleaning validation efforts to ensure seamless operations and compliance.Key Responsibilities:Lead equipment and cleaning validation...

  • Lead Validation Specialist

    3 days ago

    Durham, North Carolina, United States i-Pharm GxP Full time

    Lead Validation Consultant OpportunityWe are seeking a highly experienced Lead Validation Consultant to join our team at i-Pharm GxP. This is a unique opportunity to work on a cutting-edge project at a state-of-the-art facility in RTP, NC.The successful candidate will have a strong background in equipment and cleaning validation, with experience in...

  • Sr. Auditor, Quality Assurance

    5 days ago

    Durham, United States Proclinical Staffing Full time

    Senior Auditor for Quality Assurance - Perm - Durham, NCProclinical is currently recruiting for a dedicated Senior Auditor for Quality Assurance to join a CRO. This role focuses on maintaining and enhancing quality initiatives within the company, including SOPs and training, computer systems validation, and Quality Management System. Primary...

  • Sr. Auditor, Quality Assurance

    3 days ago

    Durham, United States Proclinical Staffing Full time

    Senior Auditor for Quality Assurance - Perm - Durham, NCProclinical is currently recruiting for a dedicated Senior Auditor for Quality Assurance to join a CRO. This role focuses on maintaining and enhancing quality initiatives within the company, including SOPs and training, computer systems validation, and Quality Management System. Primary...

  • Senior Auditor for Quality Assurance

    3 days ago

    Durham, North Carolina, United States Proclinical Staffing Full time

    Senior Auditor for Quality AssuranceProclinical Staffing is currently recruiting for a dedicated Senior Auditor for Quality Assurance to join a CRO. This role focuses on maintaining and enhancing quality initiatives within the company, including SOPs and training, computer systems validation, and Quality Management System.Key Responsibilities:Maintain the...

  • Senior Auditor for Quality Assurance

    3 days ago

    Durham, North Carolina, United States Proclinical Staffing Full time

    Senior Auditor for Quality AssuranceProclinical Staffing is seeking a dedicated Senior Auditor for Quality Assurance to join a CRO. This role focuses on maintaining and enhancing quality initiatives within the company, including SOPs and training, computer systems validation, and Quality Management System.Key Responsibilities:Maintain the Quality Management...

  • Lead Internal Auditor

    3 weeks ago

    Durham, North Carolina, United States Durham County Full time

    Position Overview:The primary objective of this role is to execute comprehensive internal audits of the County's financial records and operational systems. Responsibilities may differ based on the complexity and scope of the audit. Department: County Manager's Office General Responsibilities:This position involves conducting professional internal audits,...

  • Night Auditor

    5 days ago

    Durham, North Carolina, United States Island Hospitality Full time

    {"Job Title": "Night Auditor", "Job Summary": "We are seeking a highly motivated Night Auditor to join our team at Island Hospitality. As a Night Auditor, you will be responsible for managing all aspects of front desk operations, providing exceptional guest service, and ensuring the smooth operation of our hotel.Responsibilities:* Check-in and check-out...

  • Clinical Research Coordinator

    4 days ago

    Durham, North Carolina, United States PSI CRO Full time

    {"Job Title": "Clinical Research Coordinator", "Job Description": "Job SummaryPSI CRO is seeking a Clinical Research Coordinator to join our team. As a Clinical Research Coordinator, you will be responsible for coordinating a variety of tasks and learning new things while growing with the company.Key ResponsibilitiesCoordinate with project teams to schedule...

  • Lead Scientist in Cell and Gene Therapy

    3 weeks ago

    Durham, North Carolina, United States BioAgilytix Full time

    About BioAgilytix: At BioAgilytix, we are dedicated to exceptional science and its transformative impact on healthcare. Our team comprises highly skilled scientists and professionals who provide customized services to support groundbreaking advancements in medicine through top-tier bioanalytical services. We pride ourselves on being solution-focused and...

  • Quality Assurance Document Coordinator

    5 days ago

    Durham, North Carolina, United States Cambrex Corporation Full time

    Job Title: QA Document CoordinatorCambrex Corporation is seeking a highly organized and detail-oriented QA Document Coordinator to support our Quality Assurance team in various areas, including document archive management, data entry and trending, GxP documentation management, and general office support.Responsibilities:Organize and inventory records in a...

  • Night Auditor

    6 days ago

    Durham, North Carolina, United States CMC Hotels Full time

    Job Summary:CMC Hotels is a leading hospitality company specializing in the development, acquisition, and management of upscale hotels. We are seeking a highly skilled and detail-oriented individual to join our team as a Night Auditor.Key Responsibilities:Provide exceptional guest service and ensure the needs and safety of all guests during the check-in and...

  • Lead Operations Strategist

    3 weeks ago

    Durham, North Carolina, United States Kuehne+Nagel Full time

    Join Kuehne+Nagel as a Lead Operations StrategistAt Kuehne+Nagel, we foster a culture that values performance and recognition, providing numerous opportunities for career advancement. If you are seeking professional growth in a dynamic environment, consider the role of Lead Operations Strategist at our distribution center.Your RoleIn this position, you will...

  • Lead Operations Strategist

    3 weeks ago

    Durham, North Carolina, United States Kuehne + Nagel Full time

    Lead Operations Strategist | United States | US2078474 At Kuehne+Nagel, we foster a culture of achievement and acknowledgment, providing numerous opportunities for career advancement. If you seek professional growth or simply a rewarding workplace, consider the role of Lead Operations Strategist at our distribution center. YOUR ROLE In this position, you...

  • Quality Assurance Document Coordinator

    3 weeks ago

    Durham, North Carolina, United States Cambrex Corporation Full time

    About the RoleCambrex Corporation is seeking a highly organized and detail-oriented Quality Assurance Document Coordinator to join our team. As a key member of our Quality Assurance team, you will play a critical role in ensuring the accuracy and compliance of our documentation processes.Key ResponsibilitiesOrganize and maintain accurate and up-to-date...

  • ERP Analyst

    5 days ago

    Durham, United States Softworld, a Kelly Company Full time

    Job Title: ERP AnalystJob Location: Durham NC 27703, onsite Onsite Requirements:ERP Experience with one of the following: MS Dynamics, SAP, Oracle, NetSuite Experience in Biologics, Pharmaceutical, or other GxP environment Job Description: The ERP System Analyst (using platforms such as Microsoft Dynamics 365, SAP, Oracle, or NetSuite) will serve as the...

  • ERP Analyst

    5 days ago

    Durham, United States Softworld, a Kelly Company Full time

    Job Title: ERP AnalystJob Location: Durham NC 27703, onsite Onsite Requirements:ERP Experience with one of the following: MS Dynamics, SAP, Oracle, NetSuite Experience in Biologics, Pharmaceutical, or other GxP environment Job Description: The ERP System Analyst (using platforms such as Microsoft Dynamics 365, SAP, Oracle, or NetSuite) will serve as the...

  • Site Quality Lead

    2 months ago

    Durham, United States Strata Solar LLC Full time

    Job DescriptionJob DescriptionThe Site Quality Lead is responsible for implementing and adhering to a project’s Structural, Mechanical, and Electrical Field Quality Assurance Program and leading project staff to include Technicians and Temporary Labor. Must be fluent in Structural, Mechanical, and Electrical inspection requirements but can assist in civil,...

  • Dental Hygienist

    7 days ago

    Durham, North Carolina, United States Quality Talent Group Full time

    About the JobDental Hygienist - Quality Talent GroupJob SummaryWe are seeking a highly skilled and motivated Dental Hygienist to join our team at Quality Talent Group. As a Dental Hygienist, you will play a vital role in providing exceptional patient care and promoting oral health.Key ResponsibilitiesConduct thorough dental hygiene procedures, including...

  • Quality Assurance Specialist III

    2 weeks ago

    Durham, North Carolina, United States HUMACYTE GLOBAL INC Full time

    Job SummaryThe Quality Assurance Specialist III provides critical support to the overall Quality Assurance program at Humacyte Global Inc. Ensuring manufacturing operations are in compliance with cGMP and GTP regulations and local procedures is a key responsibility.Key ResponsibilitiesLead and provide oversight to operations on the shop floor, supporting...

Lead Quality/GxP Auditor

4 months ago

Durham, United States LS Solutions Full time

Role: Lead Quality/GxP Auditor

Location: Durham, NC, 27703 (Onsite)

Duration: 12 Months Contract


Job Description:


Identify, analyse, and determine solutions regarding capability gaps

Partner with the business to define what a qualified RTP team member looks like based on their job responsibilities – then design an appropriate curriculum

Create, revise, and implement training and related documents, ensuring they are well written, executable, and compliant with applicable policies/procedures

Facilitate the review of documents and training materials to ensure compliance and learning requirements are met


Requirements

B.S./B.A. in scientific discipline as a minimum

Minimum 3 years of GxP auditing experience in related industry

Minimum of 5 years of experience within Pharmaceutical / Biotech / Medical Device industry

Experience working in a GxP (regulated) environment.

Experience in technical writing

Demonstrated program/project management skills

Experience with learning & development business processes

Demonstrated ability to establish strong business relationships

Demonstrated ability in communication, conflict resolution, and judgment and managing complexity

Working knowledge of business area/function

Experienced in Vendor management

Ability and willingness to challenge business partners regarding ways to use learning interventions to most effectively meet business requirements

Ability to work independently and in a team environment.

Strong start-up mindset – think deliver execute review cycle

Strategic operator – think of where we need to go, but also the tactical ways to get there