Enterprise Project Document Controller

Westborough, Massachusetts


MARS Solutions Group is looking for an experienced Enterprise Project Document Controller III Westborough MA USA. Our client is a leading global Healthcare technologies and digital solutions company with an enduring and innovative presence in the industry. They foster a challenging and empowering environment that cultivates personal and professional growth.

Essential Responsibilities

Job Title/Type: QA Documentation Specialist

Function: Quality Assurance

 

Description:

The Documentation Specialist is responsible for contributing to the efforts of the QA team by establishing and/or executing sound document management and document control processes.

 

Key responsibilities include:

• Supporting and assessing QA document management processes and tools.

• Leading and/or participating in the development and implementation of employee training around document management and control.

• Participating in efforts to ensure audit-readiness and helping in the resolution of documentation issues, as required.

• Providing information and guidance to personnel with regard to the development and control of quality system documentation, as required.

• Participating in the development and maintenance of document standards and templates for QMS procedures, work instructions, and other relevant document types.

• Ensuring that documents comply with established templates, formats, and identification/naming/numbering standards.

• Supporting/managing document workflow and ensuring compliance with relevant Document Management procedures and work instructions, as required

• Ensuring that document reviews and approvals are managed in an efficient and effective manner.

• Assisting in the identification and removal of old/obsolete procedures and work instructions, as required.

• Managing and controlling specific quality records, as required.

• Assigning training activities in global learning tool.

 

 

Qualifications:

1. Bachelor's degree (or high school diploma/GED plus 3 years experience in document control in a QA/RA or medical device/pharmaceutical environment)

1. A minimum 1 year experience working in a regulated environment, preferably medical device or pharmaceutical

2. A minimum of 1 year of experience using document control strategies or methods in a regulated environment.

3. Strong working knowledge of the English language

 

Preferred Qualifications:

1. Strong knowledge of medical device and/or pharmaceutical regulations (FDA, ISO)

2. A minimum of 2 years experience in document control or training, applying regulations and/or standards such: as FDA, Sirs, ISO, etc.)

3. Strong process improvement mindset, passion for quality.

4. Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.

5. Technical aptitude (i.e. ability to comprehend and execute procedures, demonstrated understanding of system documentation).

6. Demonstrated effective interpersonal and effective teamwork skills.

7. Excellent oral and written communication skills.

8. Analytical & problem-solving skills/root-cause analysis.

9. Strong organizational skills with high attention to detail.

10. Prior experience using word processing, spreadsheet, and presentation software

 

 

About MARS Solutions Group:

MARS Solutions Group provides a range of opportunities for meaningful work by understanding that employment fit is a combination of people, process, and technology. We leverage our experienced and compassionate team to bring humanity to matching you with the right advanced technology role, and stay connected with you to help you attain your professional goals.

MARS Solutions Group is looking for an experienced Enterprise Project Document Controller III Westborough MA USA. Our client is a leading global Healthcare technologies and digital solutions company with an enduring and innovative presence in the industry. They foster a challenging and empowering environment that cultivates personal and professional growth.

Essential Responsibilities

Job Title/Type: QA Documentation Specialist

Function: Quality Assurance

 

Description:

The Documentation Specialist is responsible for contributing to the efforts of the QA team by establishing and/or executing sound document management and document control processes.

 

Key responsibilities include:

• Supporting and assessing QA document management processes and tools.

• Leading and/or participating in the development and implementation of employee training around document management and control.

• Participating in efforts to ensure audit-readiness and helping in the resolution of documentation issues, as required.

• Providing information and guidance to personnel with regard to the development and control of quality system documentation, as required.

• Participating in the development and maintenance of document standards and templates for QMS procedures, work instructions, and other relevant document types.

• Ensuring that documents comply with established templates, formats, and identification/naming/numbering standards.

• Supporting/managing document workflow and ensuring compliance with relevant Document Management procedures and work instructions, as required

• Ensuring that document reviews and approvals are managed in an efficient and effective manner.

• Assisting in the identification and removal of old/obsolete procedures and work instructions, as required.

• Managing and controlling specific quality records, as required.

• Assigning training activities in global learning tool.

 

 

Qualifications:

1. Bachelor's degree (or high school diploma/GED plus 3 years experience in document control in a QA/RA or medical device/pharmaceutical environment)

1. A minimum 1 year experience working in a regulated environment, preferably medical device or pharmaceutical

2. A minimum of 1 year of experience using document control strategies or methods in a regulated environment.

3. Strong working knowledge of the English language

 

Preferred Qualifications:

1. Strong knowledge of medical device and/or pharmaceutical regulations (FDA, ISO)

2. A minimum of 2 years experience in document control or training, applying regulations and/or standards such: as FDA, Sirs, ISO, etc.)

3. Strong process improvement mindset, passion for quality.

4. Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.

5. Technical aptitude (i.e. ability to comprehend and execute procedures, demonstrated understanding of system documentation).

6. Demonstrated effective interpersonal and effective teamwork skills.

7. Excellent oral and written communication skills.

8. Analytical & problem-solving skills/root-cause analysis.

9. Strong organizational skills with high attention to detail.

10. Prior experience using word processing, spreadsheet, and presentation software

 

 

About MARS Solutions Group:

MARS Solutions Group provides a range of opportunities for meaningful work by understanding that employment fit is a combination of people, process, and technology. We leverage our experienced and compassionate team to bring humanity to matching you with the right advanced technology role, and stay connected with you to help you attain your professional goals.