Research Quality Operations Document Manager CT
4 days ago
The Research Quality Operations Document Manager oversees the maintenance of a controlled documentation system to ensure compliance with regulatory standards and corporate policies. This role involves technical writing and editing for various documents within a modern software development environment. Responsibilities include tracking and reviewing change control documentation, as well as assisting in the editing of quality documents such as Standard Operating Procedures (SOPs), guidelines, policies, and work instructions. The ability to work swiftly while upholding high accuracy is essential.
The ideal candidate should possess strong interpersonal and information-gathering skills, enabling effective communication with individuals at all levels within the organization. The candidate should be adept at working both independently and within a team, demonstrating the ability to interact effectively with others. Additionally, responsibilities include reviewing current documents, incorporating feedback from project leaders and subject matter experts (SMEs), navigating the Veeva Document Management System (Veeva) using existing templates, and communicating workflow status and issues to project leaders or SMEs.
Position Summary
The Research Quality Operations Document Manager oversees the maintenance of a controlled documentation system to ensure compliance with regulatory standards and corporate policies. This role involves technical writing and editing for various documents within a modern software development environment. Responsibilities include tracking and reviewing change control documentation, as well as assisting in the editing of quality documents such as Standard Operating Procedures (SOPs), guidelines, policies, and work instructions. The ability to work swiftly while upholding high accuracy is essential.
The ideal candidate should possess strong interpersonal and information-gathering skills, enabling effective communication with individuals at all levels within the organization. The candidate should be adept at working both independently and within a team, demonstrating the ability to interact effectively with others. Additionally, responsibilities include reviewing current documents, incorporating feedback from project leaders and subject matter experts (SMEs), navigating the Veeva Document Management System (Veeva) using existing templates, and communicating workflow status and issues to project leaders or SMEs.
Principal Responsibilities
- You will be responsible for designing, developing, and updating change control documentation.
- Performing technical writing and editing for all types of documentation in the Veeva Document Management System.
- Tracking and reviewing change control documentation and assisting with the editing of quality documents such as SOPs, guidelines, instructions, etc., to ensure compliance with regulatory requirements.
- Reviewing current documents and incorporating comments from project leaders and other SMEs.
- Navigating through the Veeva Document Management System and using current templates.
- Notifying document authors and business owners about the workflow status and issues.
Qualifications
- Must possess sound interpersonal and information-gathering skills, enabling you to relate well to others at all levels throughout the organization
- Proficient in technical writing abilities and strong time management
- Strong root cause analysis skills with experience in quality standards
- Ability to establish working relationships with support areas to gather necessary information
- Proficient in Veeva Document Management System with proven experience in using templates, as well as knowledge of Veeva workflows, and approval processes.
- Proficient in MS Word, Excel, PowerPoint, and Outlook
- Self-motivated with a proactive approach to resolving issues
- Excellent verbal and written communication skills
- Ability to work effectively in a team environment and independently
Education
- College or university graduate preferred.
- Secondary Education diploma is a requirement.
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
-
Documentation Manager
4 days ago
New Haven, United States ACL Digital Full timeTitle: Research Quality Operations Document ManagerLocation: New Haven, CTDuration: 06 months Description: The Research Quality Operations Document Manager oversees the maintenance of a controlled documentation system to ensure compliance with regulatory standards and corporate policies. This role involves technical writing and editing for various documents...
-
New Haven, United States Nesco Resource Full timeLocation: New Haven - College St.The Research Quality Operations Document Manager oversees the maintenance of a controlled documentation system to ensure compliance with regulatory standards and corporate policies. This role involves technical writing and editing for various documents within a modern software development environment. Responsibilities include...
-
new haven, United States Nesco Resource Full timeLocation: New Haven - College St.The Research Quality Operations Document Manager oversees the maintenance of a controlled documentation system to ensure compliance with regulatory standards and corporate policies. This role involves technical writing and editing for various documents within a modern software development environment. Responsibilities include...
-
New Haven, Connecticut, United States Micro Tech Staffing - CT Full timeJob OverviewWe are seeking a highly skilled Quality Control Inspector to join our team at Micro Tech Staffing Group in CT. As a key member of our manufacturing operations, you will play a crucial role in ensuring the quality and consistency of our products.Key ResponsibilitiesUtilize precision measurement tools such as calipers, micrometers, height gauges,...
-
Quality Assurance Manager
4 days ago
New Haven, United States eTeam Full timeTitle: QA Document ManagerWork Location: New Haven, CT 06510 (100% Onsite)Pay Rate: $42.40/hrDuration: 6 Months contractReports To: Associate Director, ResearchDepartment: Quality OperationsTop Skills: Tracking and reviewing Change control documentation; GMP environment; Veeva EDMS; Technical writing; Root Cause/CAPA ManagementPosition SummaryThe Research...
-
Quality Assurance Documentation IV
3 months ago
New Haven, United States PSG Global Solutions Careers Full timeApply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Quality Assurance Documentation IV, working in Pharmaceuticals and Medical Products industry in 100 College Street, New Haven, Connecticut, United States. Job description: Perform activities for the ongoing development...
-
Clinical Research Laboratory Manager
1 week ago
New Haven, Connecticut, United States Joulé Full timeThe Clinical Research Support Laboratory (CRSL) is the primary non-CLIA certified laboratory responsible for collecting, processing, stabilizing, documenting, shipping, and tracking all research biospecimens from patients participating in clinical trials supported by the Clinical Trials Office. The Laboratory Supervisor position plays a crucial role in...
-
Clinical Research Laboratory Manager
1 week ago
New Haven, Connecticut, United States Joulé Full timeJob SummaryWe are seeking a highly skilled Laboratory Supervisor to join our team at Joulé in New Haven, CT. This is a direct hire position offering a competitive salary of $85,000 per year.About the RoleThe Clinical Research Support Laboratory (CRSL) is responsible for collecting, processing, stabilizing, documenting, shipping, and tracking research...
-
New Haven, Connecticut, United States KA Recruiting Inc. Full timeJob Title: Laboratory Operations Manager in Greater New Haven, CTAbout the Job:We are seeking a highly skilled Laboratory Operations Manager to oversee the daily operations of our laboratory in Greater New Haven, Connecticut. As a key member of our team, you will be responsible for ensuring all procedures and activities comply with safety regulations and...
-
Clinical Research Operations Manager
1 week ago
New Haven, Connecticut, United States Medix™ Full time**About the Role**We are seeking an experienced clinical research professional to lead and manage our oncology-focused clinical trials office. This role requires strong leadership, strategic oversight, and operational expertise to ensure efficient, compliant, and high-quality trial management.The ideal candidate will have extensive experience in clinical...
-
Quality Manager
1 month ago
New Haven, United States Kelly Recruiting Full timeOverview:Experienced and detail-oriented Quality Manager to be responsible for overseeing all aspects of quality assurance and control processes within our manufacturing operations. This role is critical to ensuring that our products meet the highest standards of quality, safety, and reliability. This role is on-site, New Haven, CT with an annual base salary...
-
Quality Assurance Specialist
1 week ago
New Haven, Connecticut, United States Micro Tech Staffing - CT Full timeJob DescriptionWe are seeking a Quality Assurance Specialist to join our team at Micro Tech Staffing - CT.The ideal candidate will have a strong attention to detail and be able to effectively communicate with production and engineering teams to ensure that products meet quality standards.Key Responsibilities:Utilize precision measurement tools such as...
-
New Haven, Connecticut, United States KA Recruiting Inc. Full timeJob DescriptionThis is a Laboratory Supervisor opportunity in Greater New Haven, CT.Responsibilities:Mastery of Senior Medical Technologist responsibilitiesDaily laboratory procedures including clinical procedures and monthly wipe testsOverseeing daily operations to ensure compliance with safety regulations and quality standardsSample storage and data...
-
Research Laboratory Lead
6 days ago
New Haven, United States Joulé Full timeAt Joulé, we are seeking a skilled Research Laboratory Lead to join our team in New Haven, CT. The successful candidate will have the opportunity to work with our Clinical Research Support Laboratory (CRSL), which is responsible for collecting, processing, stabilizing, documenting, and shipping various samples.About the RoleThis full-time position offers a...
-
Document Control Specialist
4 days ago
New Haven, United States Integrated Resources, Inc ( IRI ) Full timePosition Summary The Research Quality Operations Document Manager oversees the maintenance of a controlled documentation system to ensure compliance with regulatory standards and corporate policies. This role involves technical writing and editing for various documents within a modern software development environment. Responsibilities include tracking and...
-
New Haven, Connecticut, United States Medix Full timeOverviewWe are seeking an experienced Clinical Research Operations Manager to oversee and manage clinical trial operations for Medix's oncology-focused clinical trials office. This role requires strong leadership and strategic oversight to ensure operational efficiency, compliance, and quality in clinical trial management.Key ResponsibilitiesDirect and...
-
Quality Assurance/Activities
5 months ago
New Haven, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities and Requirements: Conduct and oversee quality activities to build out a clinical research site in New Haven, CT in adherence to relevant regulations and standards including as applicable; (Good Clinical Practice), FDA and sponsor requirements. Specifically, ensure that clinical equipment is handled, supplies are inventoried and...
-
Research Operations Specialist
6 days ago
New Haven, Connecticut, United States Yale University Full timeCompany Overview: Yale University is a world-renowned institution committed to excellence in education, research, and patient care. Our YCCI Research Administration team plays a vital role in supporting the academic mission of the university.Job Summary: We are seeking an experienced Research Operations Specialist or Program Development Lead to join our...
-
Early Learning Program Manager
6 days ago
New Haven, Connecticut, United States Creating Kids at the CT Children's Museum Full timeCreating Kids at the CT Children's Museum seeks a skilled Early Learning Program Manager to oversee daily operations and staff in its early learning program. This dynamic role requires strong leadership, planning, and coordination skills to develop and implement programs that meet the needs of young learners.As a key member of our team, you will work closely...
-
Plant Genetics Research Scientist
7 days ago
New Haven, Connecticut, United States Joulé Full timeJob Title: Senior Scientist Plant GeneticsWe are seeking an experienced Senior Scientist Plant Genetics to join our team at Joulé. This is a direct hire position, full time and based in New Haven, CT.About the JobLocation: New Haven, CT, United States - Schedule/Hours: Monday - Friday, Full-time - Type: Direct HireResponsibilitiesMaintenance of plant tissue...
