Current jobs related to GXP Compliance Expert - Wilmington, Delaware - Compunnel Inc.

  • Digital Quality Management Systems Director

    2 weeks ago

    Wilmington, Delaware, United States Incyte Full time

    Job SummaryThe Director to Sr. Director, Digital Quality Management Systems (QMS) programs leads the digitalization of the Quality Management System at Incyte, a biopharmaceutical company focused on discovering, developing, and commercializing novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity.This role is...

  • Compliance Counsel

    1 week ago

    Wilmington, Delaware, United States Chemours Full time

    Empowering a Culture of ComplianceChemours is seeking a highly skilled Compliance Counsel to join our growing Ethics & Compliance team. This role will play a critical part in supporting the continued evolution of our global compliance function, including policy drafting, risk assessments, and remediation plans.Key Responsibilities:Investigate ethics matters...

  • Compliance Counsel

    2 weeks ago

    Wilmington, Delaware, United States The Chemours Company Full time

    Compliance Counsel Job DescriptionChemours is seeking a highly skilled Compliance Counsel to join our growing Ethics & Compliance team. As a key member of our team, you will play a critical role in supporting the continued evolution of our global compliance function.Key Responsibilities:Investigate ethics matters reported to the Company, conducting thorough...

  • Audit Manager, Consumer Compliance Expert

    2 weeks ago

    Wilmington, Delaware, United States Tech Brains Solutions, Inc. Full time

    Job Title: Audit Manager, Consumer ComplianceAt Tech Brains Solutions, Inc., we are seeking an experienced Audit Manager, Consumer Compliance to join our team. As a key member of our audit team, you will be responsible for overseeing assigned areas of audit work, acting as an Auditor-in-Charge (AIC), and executing on the audit strategy for Lines of Business...

  • Lead GRC Compliance Specialist

    1 week ago

    Wilmington, Delaware, United States Motion Recruitment Full time

    Are you an experienced GRC professional looking for a challenging role in a dynamic healthcare SaaS company? We have an exciting opportunity for a Lead GRC Analyst at an innovative business located in Wilmington, DE; this company is transforming the healthcare industry with cutting-edge software solutions that streamline the EMR and healthcare billing...

  • Audit Manager, Consumer Compliance Expert

    3 weeks ago

    Wilmington, Delaware, United States Tech Brains Solutions, Inc. Full time

    Job SummaryThis role is responsible for overseeing assigned areas of audit work, acting as an Auditor-in-Charge (AIC), and executing on the audit strategy for Lines of Business (LOBs). The successful candidate will drive risk-based auditing by defining scope and test procedures to evaluate the control environment in conformance with audit policies, assess...

  • Culinary Expert

    1 week ago

    Wilmington, Delaware, United States Habit Burger Grill Full time

    Job DescriptionWe are seeking a skilled Culinary Expert to join our team at Habit Burger Grill. As a key member of our kitchen staff, you will be responsible for preparing and cooking high-quality food items to meet the standards of our customers.Key Responsibilities:Manage kitchen operations to ensure efficient food preparation and service.Supervise and...

  • Data Reporting Analyst

    7 days ago

    Wilmington, Delaware, United States VDart Full time

    Job Role: Sr. Data Reporting AnalystJob Summary:As a Sr. Data Reporting Analyst at VDart, you will be responsible for designing and formatting reports to meet business needs and standards. You will collaborate with stakeholders to understand business requirements for reporting needs and ensure compliance with regulatory requirements and company policies.Key...

  • Environmental Project Manager

    2 weeks ago

    Wilmington, Delaware, United States Montrose Environmental Group, Inc. Full time

    About the RoleWe are seeking an experienced Environmental Project Manager to join our team at Montrose Environmental Group, Inc. As a key member of our Environmental Engineering and Consulting team, you will be responsible for managing a variety of environmental compliance projects, including Spill Prevention, Control, and Countermeasure Plans, Stormwater...

  • Program Manager

    2 weeks ago

    Wilmington, Delaware, United States V-Soft Consulting Group, Inc Full time

    Job Title: Program Manager - Infosec and Patch Management ExpertV-Soft Consulting Group, Inc is seeking a highly skilled Program Manager to lead our Infosec and Patch Management efforts. The ideal candidate will have a strong background in IT security and vulnerability management, with experience in managing small to medium-sized teams in a large IT...

  • Regulatory Expert

    1 month ago

    Wilmington, Delaware, United States Celanese Full time

    Job SummaryCelanese is seeking a highly motivated and detail-oriented Regulatory Professional to join our growing Product Stewardship team. In this role, you will be responsible for ensuring our company's compliance with key chemical regulations in North America.Key ResponsibilitiesEnsure marketability of Celanese products under regulatory aspects, in...

  • Operational Expert

    1 week ago

    Wilmington, Delaware, United States Reading Co-Operative Full time

    As a key member of the Reading Cooperative Bank team, you will play a vital role in driving the success of our branches by overseeing daily operations and leading a team of professionals.You will be responsible for ensuring our customers receive exceptional service, which includes presenting them with tailored financial solutions that meet their unique...

  • Senior Mechanical Engineer

    1 week ago

    Wilmington, Delaware, United States Charles River Laboratories Full time

    Job SummaryServe as a Subject Matter Expert for mechanical utility systems and energy optimization. Work with all business units to conduct energy audits and identify saving opportunities. Support all business units with technical knowledge in mechanical utilities and energy efficiency for project reviews and trouble shooting.Key Responsibilities:Provide...

  • ForgeRock Expert

    1 week ago

    Wilmington, Delaware, United States Diverse Lynx Full time

    Role Overview:As a skilled ForgeRock Developer at Diverse Lynx LLC, you will be responsible for implementing and designing Identity and Access Management solutions. This role requires a strong understanding of ForgeRock technology and Agile methodologies.Key Responsibilities: Implement and maintain ForgeRock solutions Collaborate with cross-functional teams...

  • Enterprise Architect

    2 weeks ago

    Wilmington, Delaware, United States Insight Global Full time

    Job Title: Enterprise Architect - Data & Analytics ExpertJob Summary:We are seeking a highly skilled Enterprise Architect with expertise in Data & Analytics to support projects related to ESG (environmental, social, governance) within R&D and manufacturing.Key Responsibilities:Provide technical expertise across enterprise, global, and regional initiatives to...

  • Pharmacist - Medication Expert

    2 weeks ago

    Wilmington, Delaware, United States International SOS Full time

    About the CompanyInternational SOS is a leading provider of medical and security risk management solutions, delivering customized services to enable clients to operate safely and effectively in environments far from home.With a global presence in 92 countries, our integrated medical solutions cater to organizations with international operations, focusing on...

  • Senior Associate Forensic Chemist

    2 months ago

    Wilmington, Delaware, United States Montrose Environmental Group Full time

    About the RoleWe are seeking a highly skilled Senior Associate Forensic Chemist to join our team at Montrose Environmental Group. As a key member of our Environmental Standards Forensic team, you will be responsible for a full range of activities including data validation, laboratory procedural review, and environmental data interpretation.Key...

  • Software Architect

    2 weeks ago

    Wilmington, Delaware, United States Diverse Lynx Full time

    Role Overview:As a Software Architect at Diverse Lynx LLC, you will be responsible for designing and implementing ForgeRock solutions that meet the needs of our clients. With a strong background in Identity and Access Management, you will work closely with our development team to create scalable and secure systems.Key Responsibilities:Design and implement...

  • Sterile Production Expert

    2 months ago

    Wilmington, Delaware, United States Alkermes Full time

    Job SummaryWe are seeking a highly skilled and experienced Manufacturing Process Technologist to join our team at Alkermes. As a key member of our manufacturing team, you will be responsible for supporting the Vivitrol formulation manufacturing process and ensuring the highest quality and efficiency standards are met.Key ResponsibilitiesSupport on-going...

  • Senior Financial Analyst

    1 week ago

    Wilmington, Delaware, United States Beacon Hill Full time

    Accounting Compliance ExpertBeacon Hill is seeking an experienced accounting professional to join their external reporting team. The ideal candidate will have a strong background in GAAP and SOX guidelines, with expertise in preparing SEC reporting materials and conducting financial analyses.Key Responsibilities: Prepare 10K and 10Q reports Analyze balance...

GXP Compliance Expert

2 months ago

Wilmington, Delaware, United States Compunnel Inc. Full time

Job Summary:

The Computer System Validation (CSV) Specialist will support the Newark manufacturing facility with validation of new and existing computerized systems. This role will primarily support the Newark manufacturing facility but may require some travel to other North American sites as needed.

Key Responsibilities:

  • Support the Data Integrity Manager with validation of automated equipment and control systems.
  • Execute test scripts, create, and modify draft protocols to ensure compliance with regulatory requirements.
  • Review previously executed CSV activities, identify gaps, and implement revisions to GMP documentation.
  • Collaborate with cross-functional teams to create and modify validation documentation.
  • Write reports summarizing the results of protocol executions, highlighting key findings and recommendations.

Requirements:

  • Bachelor's degree in computer science, engineering, or a related field.
  • Minimum of 2-3 years of experience working with automation and/or computerized system validations.
  • Direct experience in validation of computer/automation/software validation, including IQ, OQ, and PQ protocols, deviation resolution, and final summary reports.
  • Strong written and oral communication skills, with the ability to effectively communicate with technical and non-technical stakeholders.
  • Strong organizational and time management skills, with the ability to prioritize tasks and meet deadlines.
  • Experience working in a GXP environment, with a strong understanding of regulatory requirements.