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Job Function:

Quality

Job Sub Function:

Quality Documentation

Job Category:

Business Enablement/Support

All Job Posting Locations:

Grecia, Costa Rica

Job Description:

All Dedicated Depuy Synthes roles will require specific job posting language you will find below. Please include this in all new dedicated DePuy Synthes postings that go up. "Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone Orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes

JOB SUMMARY*

 

The Document Change Analyst executes change-control activities for controlled documents within the document management system. This role additionally coordinates guidance to internal customers on how to execute the change control process and ensuring adherence to established standards.

DUTIES & RESPONSIBILITIES*

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Reviewing changes in a timely manner for compliance with procedures

• Review accuracy and consistency of document changes submitted, according to internal procedures.

• Selecting or verifying approvers of changes per procedures

• Collecting and reporting metrics pertaining to change control activities

• Manage projects that help support departmental objectives, including projects that require collaboration with other departments or facilities

• Support and recommend change management process improvements

• Support both internal and external audits, as well as quality events, relating to the change control processes

• Ensure all activities are following the documented quality system and current regulatory requirements
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION*

• Technical Degree completed. Mandatory -(Quality Technician preferred)
• 2-4 years of business experience, including a minimum of 2 years with electronic change control experience in medical device or pharmaceutical industry (Mandatory)

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Bilingual or Fluent in English / Spanish desired

• Computer skills and proficiency in Microsoft Office (i.e., Word, Excel, PowerPoint, E-mail).

• Ability to learn software applications associated with Document & Data Control (Product Lifecycle Management - PLM system).

• Experience in Electronic change control processes and PLM systems (i.e., Windchill, ADAPTIV, etc.) in a regulated industry is highly desirable.

• GMP/ ISO knowledge preferred.

• Strong verbal, written and active listening skills.

• Ability to organize, prioritize, and handle multiple projects simultaneously.

• Ability to communicate effectively   and   in   a   professional   manner   with   all   levels   of   the organization and with different functional groups.

• Ability to perform duties in accordance with policies and procedures complying with applicable requirements.

• Ability to work collaboratively with a team or independently, with an eye for detail and methodical approach.

 

 

Required Skills:

 

 

Preferred Skills:

Accountability, Administrative Support, Compliance Management, Data Gathering and Analysis, Data Reporting, Detail-Oriented, Document Management, Execution Focus, Goal Attainment, Organizing, Process Oriented, Project Support, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Systems Documentation, Technical Writing, Time Management