- Change Control Management: Utilize Oracle for initiation of Engineering Change Orders (ECOs), ensuring accurate documentation of changes and adherence to regulatory requirements and guidelines.
- Quality Management Systems (QMS): Maintain and improve the QMS documentation, ensuring alignment with regulatory standards (e.g., FDA, ISO).
- Veeva DCC Initiation: Initiate and manage documents within the Veeva Document Change Control (DCC) system, Aiding engineering in the document lifecycle from creation to archival.
- Track Wise Digital: Utilize Track Wise digital platform for managing deviations, investigations, corrective and preventive actions (CAPAs), and other quality events, ensuring timely resolution and documentation.
- Change Request (CR) Creation: Generate and manage Change Requests within designated systems, facilitating cross-functional communication and documentation of change initiatives.
- Training and Compliance: Collaborate with training teams to ensure documents are appropriately linked to training requirements, facilitating compliance with regulatory and internal standards.
- Continuous Improvement: Identify opportunities for process optimization and efficiency gains within the document control processes, driving continuous improvement initiatives.
- Cross-Functional Collaboration: Work closely with stakeholders across departments (e.g., Quality Assurance, Regulatory Affairs, Manufacturing) to ensure documentation requirements are met and maintained.
- Bachelor's Degree in a relevant field.
- 2-5 years relevant work experience
- Proven experience in documentation management within a regulated industry, such as pharmaceuticals, biotechnology, medical devices, or similar.
- Proficiency in using Oracle for ECO implementation and Track Wise digital for document and quality event management.
- Experience with Veeva DCC initiation and management is highly desirable.
- Strong understanding of document control principles, quality management systems, and regulatory requirements (e.g., FDA, ISO).
- Excellent attention to detail and organizational skills, with the ability to manage multiple tasks simultaneously.
- Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and influence stakeholders at all levels.
- Analytical mindset with problem-solving abilities, capable of identifying process improvements and driving change initiatives.
- Familiarity with electronic document management systems (EDMS) and proficiency in MS Office Suite.
- Commitment to upholding quality standards, integrity, and confidentiality in document management practices.
-
Document Specialist
1 week ago
Randstad Life Sciences US Burlington, United StatesTitle: Document Control and Records Management · Duration: 06 months Contract · Location: Burlington, MA · Max PR: $40.00 · Shift: Third Shift · HM open to Day shift Mon-Fri, 8 hour shift, or Wed-Sat hr our shifts) · Description: · The Specialist role supporting Document Contro ...
-
Document Specialist
3 days ago
Talent Groups Marlborough, United StatesDevelop, produce, and maintain technical and user documentation. · - Plan and execute writing projects with attention to complex technical content. · - Present content effectively and report progress in meeting schedule milestones. · - Utilize word processing tools proficiently. ...
-
Document Control Specialist
1 week ago
Metal Works Inc Londonderry, United StatesThis position is considered entry level to start and with a lot of opportunity for growth The pay is up to $18/hr. The hours are 7-3:30 or 8-4:30pm Monday through Friday. · **Job Summary** · This position will be responsible for creating, maintaining, and updating customer and co ...
-
R&d Document Specialist Ii
2 weeks ago
Teleflex Chelmsford, United States**Date**:Apr 18, 2024 · **Location**: Chelmsford, MA, US · **Company**:Teleflex · **Expected Travel**: Up to 10% · **Requisition ID**: 10227 · **About Teleflex Incorporated** · **Interventional -** The Interventional business unit at Teleflex offers innovative medical devices tha ...
-
South Shore Health Weymouth, United States**Job Description Summary** · Under the general supervision of the Manager of Clinical Documentation, will assist to develop, implement, and maintain the documentation accuracy initiative at the Hospital. This position is responsible for the concurrent review of the clinical docu ...
-
Mds/managed Care Documentation Specialist
1 week ago
The Courville at Nashua Nashua, United States**Growth Opportunity** · **The Courville at Nashua **is a Senior Healthcare Community in Nashua, NH. We are locally owned and operated and committed to providing personalized service and care. We're looking for **Full-time MDS/Managed Care Documentation Specialist (RN preferred) ...
-
Document Quality Control Specialist
2 weeks ago
The Adecco Group Bedford, United StatesA Document Quality Control Specialist position (fully remote) is now available through Adecco Medical and Science. In this role, you will be responsible for the quality control review of scientific documents within the Translational DMPK and Clinical Control Specialist, Quality C ...
-
Document Control Specialist I
3 weeks ago
Werfen Bedford, United StatesOverview · Werfen · Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. ...
-
Document Quality Control Specialist
2 weeks ago
Adecco US, Inc. Bedford, United StatesA Document Quality Control Specialist position (fully remote) is now available through Adecco Medical and Science. In this role, you will be responsible for the quality control review of scientific documents within the Translational DMPK and Clinical Pharmacology group. This posi ...
-
Document Quality Control Specialist
2 weeks ago
Adecco USA Bedford, United StatesA Document Quality Control Specialist position (fully remote) is now available through Adecco Medical and Science. In this role, you will be responsible for the quality control review of scientific documents within the Translational DMPK and Clinical Pharmacology group. This posi ...
-
Document Quality Control Specialist
2 weeks ago
Adecco USA Bedford, United StatesA Document Quality Control Specialist position (fully remote) is now available through Adecco Medical and Science. In this role, you will be responsible for the quality control review of scientific documents within the Translational DMPK and Clinical Pharmacology group. This posi ...
-
Documentation Specialist
2 weeks ago
Cortron Inc Lowell, United States Part timeJob Location · Cortron Inc. · 59 Technology Dr · Lowell, MA 01851 · About Our Company: · Cortron, Inc., founded in 1969, is a privately held, AS9100 registered manufacturing company located in Lowell, MA. We provide unique solutions to complex data-entry problems for defense and ...
-
Documentation Specialist
9 hours ago
Teleflex Chelmsford, United StatesDocumentation Specialist · Date: May 31, 2024 · Location: Chelmsford, MA, US · Company: Teleflex · Expected Travel : None · Requisition ID :10151 · About Teleflex Incorporated · Teleflex is a global provider of clinically effective medical technologies designed to improve the hea ...
-
Clinical Documentation Specialist
1 week ago
Emerson Hospital Concord, United States Full timeReporting to the Director of Medical Records the Clinical Documentation Specialists facilitates improvement in the overall quality, completeness, and accuracy of medical record documentation for the purposes of ensuring compliance with Medicare and Medicaid (CMS) regulations and ...
-
Document Quality Control Specialist Contractor
2 weeks ago
Apex Systems Bedford, United States FreelanceDocument Quality Control Specialist Contractor Location:Greater Boston, MA (Hybrid)Science:Advanced Biologic therapyJob Overview: This role, for a Document QC Specialist Contractor, will manage the quality control of scientific documents and Bioanalytical data for the Translation ...
-
Documentation Specialist
2 weeks ago
Talent Groups Marlborough, United StatesBachelor's degree OR a high school education and a minimum of 3 years experience in a GMP controlled environment. · Coordinate the control of Quality Management System (QMS) and GMP critical documentation. · Manage document reviews and approvals efficiently. · Maintain accurate r ...
-
Document Preparation Specialist
3 weeks ago
Global Channel Management Lynnfield, United StatesExperience in Document Preparation NeededExperience And ResponsibilitiesAre you looking for a role in Document Preparation that requires 1+ years of experience? This position involves administrative support, clerical tasks, and document preparation. Don't worry if you're new to t ...
-
Kiniksa Pharmaceutical Lexington, United StatesReporting to the Associate Director, Quality Management Systems, the Specialist/Sr. Specialist, Quality - Document Control and Training will be responsible for wide variety of activities pertaining to Document Control, Records Management, Training, and Improving Kiniksa's Quality ...
-
Clinical Documentation Specialist
1 week ago
Emerson Hospital Concord, United StatesClinical Documentation Specialist · Job Ref: 29018 · Category: Professional & Management · Location: · Emerson Hospital, · 133 Old Road to Nine Acre Corner, · Concord, · MA 01742 · Department: Medical Records · Schedule: Full Time · Shift: Day shift · Hours: 730-4 · Repo ...
-
Clinical Documentation Specialist
1 week ago
Emerson Hospital Concord, United StatesReporting to the Director of Medical Records the Clinical Documentation Specialists facilitates improvement in the overall quality, completeness, and accuracy of medical record documentation for the purposes of ensuring compliance with Medicare and Medicaid (CMS) regulations and ...
Engineering Document Specialist II - Burlington, United States - Glaukos Corporation
Description
Job DescriptionGLAUKOS - ENGINEERING DOCMENTATION SPECIALIST II (BURLINGTON, MA)
How will you make an impact?
We are seeking a meticulous and detail-oriented Engineering Documentation Specialist to join our team. The ideal candidate will be responsible for ensuring the accuracy, completeness, and compliance of all documentation related to our processes and products. This role requires proficiency in utilizing various software tools, including Oracle for ECO implementation, Veeva for DCC initiation, Track Wise digital, and CR creation and documentation. The Engineering Documentation Specialist will play a crucial role in maintaining quality standards and regulatory compliance within our organization.
What will you do?
About Us
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.
Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.
Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
