Document Management Specialist at Johnson & Johnson

Raynham, Massachusetts, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, OrthopaedicsIndustries

Requirements

University/Bachelors Degree (or equivalent 4 year degree)
Minimum of 1 year with electronic change control experience in regulated industry (medical device or pharmaceutical industry preferred)

Responsibilities

Executing change control processes related to the change control oversight of DePuy Synthes changes, including:
Reviewing changes in a timely manner for compliance with procedures
Selecting or verifying approvers of changes per procedures
Collecting and reporting metrics pertaining to change control activities
Communicating the status of changes
Manage small projects that help support departmental objectives, including projects that require collaboration with other departments or facilities
Support and recommend change control process improvements
Support both internal and external audits, as well as quality events, relating to the change control processes
Ensure all activities are in compliance with the documented quality system and current regulatory requirements

Skills

Key technologies and capabilities for this role

Document ManagementQuality DocumentationQuality AssuranceOrthopaedicsMedical Devices

Questions & Answers

Common questions about this position

What is the work arrangement for this Document Management Specialist role?

This is a hybrid role available in multiple US locations including Palm Beach Gardens, FL; Raynham, MA; Warsaw, IN; and West Chester, PA.

What are the main responsibilities of the Document Management Specialist?

The role involves executing change control processes for changes to Device Master Records, Quality System Record data, and documents in the PLM system (Windchill), and providing guidance to internal customers on change control procedures.

What is the salary for this position?

This information is not specified in the job description.

What companies will this role be associated with?

The position is currently with Johnson & Johnson, but following a planned separation of the Orthopaedics business within 18-24 months, it will transition to DePuy Synthes, with employment governed by their processes, policies, and benefits.

What experience is needed to be a strong candidate for this role?

Strong candidates will have expertise in change control processes, Device Master Records, Quality System Records, and the Windchill PLM system, ideally with experience in quality documentation within orthopaedics or medical devices.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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