Sr. Document Control Specialist in Carlsbad, California at SCIEX

Date Posted: 8/5/2019

Job Snapshot

Job Description

Job ID: SCI003344

About Us

SCIEX – An operating company within Danaher’s Life Sciences platform

SCIEX helps to improve the world we live in by enabling scientists and laboratory analysts to find answers to the complex analytical challenges they face. Our leadership in LC-MS and CE-MS have made us a trusted partner globally to those who are focused on basic research, drug discovery, food and environmental testing, forensic toxicology, clinical research and diagnostics. With over 40 years of innovation, we continue to redefine what is achievable in routine and complex analysis.

We are seeking smart, team-oriented people who have purpose and are committed to helping us deliver Answers for Science. Knowledge for Life. ™ Our global team, located on every continent, is our greatest strength, bringing diverse perspectives and breakthrough thinking. With the power of the Danaher Business System behind us, it’s our people who have made us the industry leader. Come join our winning team. Visit us at www.sciex.com.



Description

Essential Duties, Critical Success Factors, Responsibilities, Authorities and Required Interactions: 
  • Reporting to the Manager of CE Consumables Sustainment, this role will have accountability for creation, maintenance, control, and distribution of all documents necessary to define consumables products for the CE-Biopharma Business Unit and ensure conformance to customer requirements, ISO standards and applicable regulations. The qualified candidate will develop and maintain a comprehensive review, approval & filing system and computer database for all documents to be retained in the document control system. This role will also be accountable to manage document control to ensure that all stakeholders have access to the latest revision of appropriate documentation in a timely manner.
  • Job Responsibilities: 
  • Collect and maintain files of the latest revision level documentation necessary to define product configuration.
  • Ensure timely distribution of latest revision level documentation to all appropriate users and obsolete documentation removal.
  • Maintain a computer database of all filed documentation that ensures fast retrieval of documents. Control access and provide user support and training.
  • Implement changes based on red-lines and format engineering documents per documentation standards 
  • Control and manage appropriate document templates. 
  • Ensure guidelines and definitions are consistently applied across templates and documents.
  • Advise and respond to queries on document change management by interfacing with document owners and originators of changes, providing prior and current revisions of documents, and running queries and reports.
  • Review all documentation for accuracy, completeness and consistency in content, format, files and authorizations.
  • Filing, scanning, copying and electronic notification and distribution of released documentation.
  • Store and control archived documentation.
  • Maintain physical security of the document control file cabinets and contents.
  • Ensure that all document control systems adhere to applicable ISO 9001 and ISO 13485 standards.
  • Participate in the internal auditing process as required.

Job Requirements



Qualifications

  • Bachelor’s degree in field with no less than 5+ years of industry experience OR Master’s degree in field with 3+ years of industry experience OR Doctoral degree in field with 0-2 years of industry experience.  
  • Prior experience with documentation of Life Science or Medical Device products.
  • Strong business acumen with customer focus.
  • History of getting results through others, with the ability to work in a matrixed environment. 
  • Strong communication skills, both written and verbal.
  • Ability to use and apply using logic and critical thinking skills.
  • Experience with change orders.  
  • Knowledge of document control procedures including database storage, maintenance, and revision control




 D&I Statement

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

SCIEX is an equal opportunity employer, and only those candidates who are qualified will be contacted.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.