Document Control Specialist

7 days ago

Somerville, United States Deephealth Full time

**Job Description**:
**Job Summary**

The Document Control Specialist is primarily responsible for managing and maintaining the records required to support the Quality Management System, including product and product development, and business activities. The Document Control Specialist will also support the Quality and Regulatory team by performing general quality system activities.

**Essential Duties and Responsibilities**
- Lead the maintenance and continuous improvement of the Document Management System (DMS)
- Work with team members to ensure technical documentation and filings are complete and reflect current practice
- Ensure maintenance of technical and business related documentation, including routing, approval, and storage of electronic records.
- Enforce compliance to applicable standards and escalate to appropriate authorities if needed.
- Support regulatory, customer, and internal audits.
- Assist in general tasks to support the maintenance and improvement of the Quality Management System

PLEASE NOTE: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time.

**Minimum Qualifications, Education and Experience**
- Associate’s degree in relevant field (or equivalent experience)
- 2 - 4 years working in a regulated industry (FDA and Software as a Medical Device preferred) as a document control specialist
- Experience creating and maintaining both paper and electronic records
- Basic knowledge and understanding of Quality System Regulations, including but not limited, to 21 CFR 11, 21 CFR 820, and ISO 13485.
- Experience interacting with Regulatory Authorities
- Excellent written and oral communication skills, including English

**Quality Standards**
- Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, patients, visitors, and vendors.
- Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
- Follows all local, state and federal laws concerning employment to include but not limited to: I-9, Harassment, EEOC, Civil rights and ADA.
- Follows OSHA regulations, RadNet and site protocols, policies and procedures.
- Follows HIPAA, compliance, privacy, safety and confidentiality standards at all times.
- Practices universal safety precautions.
- Promotes good public relations on the phone and in person.
- Adapts and is willing to learn new tasks, methods, and systems.
- Reports to work regularly as scheduled; consistently punctual with respect to working hours, meal and rest breaks, and maintains satisfactory personal attendance in accordance with RadNet guidelines.
- Consistently adheres to the time management policies and procedures.
- Completes job responsibilities in a quality and timely manner.

**Physical Demands**

This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation.

**Working Environment**

Remote setting.

Pay Range: USD $70,000.00 - USD $80,000.00 /Yr. Shift: Flexibility Required Shift Variations: Monday
- Friday, 40 hours

  • Document Control Specialist

    4 weeks ago

    Somerville, United States RadNet Full time

    Job DescriptionJob DescriptionResponsibilitiesJob SummaryThe Document Control Specialist is primarily responsible for managing and maintaining the records required to support the Quality Management System, including product and product development, and business activities. The Document Control Specialist will also support the Quality and Regulatory team by...

  • Document Control Specialist

    4 weeks ago

    Somerville, United States DeepHealth Full time

    Job Description: Job Summary The Document Control Specialist is primarily responsible for managing and maintaining the records required to support the Quality Management System, including product and product development, and business activities. The Document Control Specialist will also support the Quality and Regulatory team by performing general quality...

  • Document Control

    3 weeks ago

    Somerville, United States Evers and Sons Full time

    Job DescriptionJob DescriptionJob Opportunity: Document Control SpecialistOverview: Join Evers & Sons Inc., a family-owned leader in the energy sector since 1981. As a Document Control Specialist, you will play a crucial role in managing and safeguarding project documentation. This position requires a detail-oriented and organized professional to ensure the...

  • Environmental Cleaning Specialist

    2 weeks ago

    Somerville, United States Planet Pharma Full time

    Summary:Specializes in working in facilities that manufacture a finished product for sale, or sale to another organization for use in an end product. Performs microbial control cleaning procedures that must comply with current Good Manufacturing Practices (cGMP) and regulatory guidelines which include documentation of work procedures frequently audited by...

  • Clinical Document Specialist

    2 months ago

    Somerville, United States RWJ Barnabas Full time

    Responsibilities: Bridging the gap between the Physician documentation and the Coding professional through compliance review of inpatient charts. Communicate in person, through query documents, via telephone with Physicians to improve or complete documentation necessary for appropriate coding compliance. Provide educational materials and seminars to...

  • Clinical Document Specialist

    4 weeks ago

    Somerville, United States RWJ Barnabas Full time

    Responsibilities: Bridging the gap between the Physician documentation and the Coding professional through compliance review of inpatient charts. Communicate in person, through query documents, via telephone with Physicians to improve or complete documentation necessary for appropriate coding compliance. Provide educational materials and seminars to...

  • LL01-030524 Project Manager for CQV Documentation Project

    4 weeks ago

    Somerville, United States Validation & Engineering Group Full time

    Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a...

  • Is Service Desk Specialist

    3 weeks ago

    Somerville, United States Mass General Brigham Full time

    **IS Service Desk Specialist** - (3288527) **The Opportunity** The Service Desk Support Specialist I is responsible for providing technical support services to end users via telephone, including software setup, configuration and troubleshooting. Requests may also be received via an online portal. **The duties; **Service Desk Support Specialist role** -...

  • Controls Engineer

    2 weeks ago

    Somerville, United States Commonwealth Fusion Systems Full time

    Commonwealth Fusion Systems (CFS) has the fastest, lowest cost path to commercial fusion energy.CFS collaborates with MIT to leverage decades of research combined with groundbreaking new high-temperature superconducting (HTS) magnet technology. HTS magnets will enable compact fusion power plants that can be constructed faster and at lower cost. Our mission...

  • Controls Engineer

    4 weeks ago

    Somerville, United States Commonwealth Fusion System Full time

    Commonwealth Fusion Systems (CFS) has the fastest, lowest cost path to commercial fusion energy. CFS collaborates with MIT to leverage decades of research combined with groundbreaking new high-temperature superconducting (HTS) magnet technology. HTS magnets will enable compact fusion power plants that can be constructed faster and at lower cost. Our mission...

  • Controls Engineer

    2 days ago

    Somerville, United States Commonwealth Fusion System Full time

    Commonwealth Fusion Systems (CFS) has the fastest, lowest cost path to commercial fusion energy. CFS collaborates with MIT to leverage decades of research combined with groundbreaking new high-temperature superconducting (HTS) magnet technology. HTS magnets will enable compact fusion power plants that can be constructed faster and at lower cost. Our mission...

  • Quality Control Manager

    4 weeks ago

    Somerville, United States Digital Prospectors Full time

    Position: Quality Control Manager (Lab Operations) Location: Somerville, MA (Onsite) Length: 6+ months Covid Requirements: N/A Job Description: Our client is looking for a Quality Control Manager who will be responsible for quality control laboratory operations and GMP method performance of analytical chemistry and molecular based assays. The Quality...

  • Quality Control Manager

    2 weeks ago

    Somerville, United States Digital Prospectors Full time

    Position: Quality Control Manager (Lab Operations) Location: Somerville, MA (Onsite) Length: 6+ months Covid Requirements: N/A Job Description: Our client is looking for a Quality Control Manager who will be responsible for quality control laboratory operations and GMP method performance of analytical chemistry and molecular based assays. The Quality...

  • Quality Control Manager

    1 month ago

    Somerville, United States Digital Prospectors Full time

    Position: Quality Control Manager (Lab Operations)Location: Somerville, MA (Onsite)Length: 6+ monthsCovid Requirements: N/AJob Description:Our client is looking for a Quality Control Manager who will be responsible for quality control laboratory operations and GMP method performance of analytical chemistry and molecular based assays. The Quality Control...

  • Quality Control Manager

    2 weeks ago

    Somerville, United States Digital Prospectors Full time

    Position: Quality Control Manager (Lab Operations)Location: Somerville, MA (Onsite)Length: 6+ monthsCovid Requirements: N/AJob Description:Our client is looking for a Quality Control Manager who will be responsible for quality control laboratory operations and GMP method performance of analytical chemistry and molecular based assays. The Quality Control...

  • Quality Control Manager

    4 weeks ago

    Somerville, United States Digital Prospectors Full time

    Position: Quality Control Manager (Lab Operations)Location: Somerville, MA (Onsite)Length: 6+ monthsCovid Requirements: N/AJob Description:Our client is looking for a Quality Control Manager who will be responsible for quality control laboratory operations and GMP method performance of analytical chemistry and molecular based assays. The Quality Control...

  • Quality Assurance Specialist

    2 weeks ago

    Somerville, United States Deephealth Full time

    **Job Description**: Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, RadNet is _Leading Radiology Forward_. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of RadNet’s success is its people with the commitment to a better healthcare experience. When...

  • Customer & Operations Specialist

    1 month ago

    Somerville, United States Century Linen & Uniform Full time

    Essential Functions: * Deliver Exceptional Customer Experience: The Customer & Operations Specialist consistently upholds the Century's customer experience strategy by taking ownership of customer cases. This entails delivering an experience that aligns with the established service vision, standards, and values for all Angelica customers. * Handling...

  • Quality Assurance Specialist

    2 weeks ago

    Somerville, Massachusetts, United States RadNet Full time

    Responsibilities: Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, RadNet is Leading Radiology Forward. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of RadNets success is its people with the commitment to a better healthcare experience. When you join...

  • Recovery Specialist

    2 weeks ago

    Somerville, United States Bay Cove Human Services Full time

    Bay Cove Human Services’ mission is to partner with people to overcome challenges and realize personal potential. Bay Cove pursues this mission by providing individualized and compassionate services to people facing the challenges associated with developmental disabilities, mental illness, substance use disorders, and homelessness at more than 175 program...