Location: Colorado Springs,CO
Are you an expert at supporting your teammates in all the aspects of documentation? Do you have the drive to support change management processes and assist in documentation excellence for the entire organization?
If your answer is yes, then we may be looking for you!
Spectranetics, recently named “Most Trusted Companies”, has an opening for a Document Control Specialist.
What You Will Do: You will assist in the change management process to encompass documented processes, procedures, projects, and product. The Document Control department will support the change management process with system and process support and ensure the use of current, relevant, and approved documentation. Your primary role will revolve around control of all forms of documentation.
What You Will Learn: Spectranetics attracts and hires the best talent on the planet! You will be working with a great team of dedicated experts and leaders in the Medical Device Industry who will support your continued growth. You will learn about all facets of state of the art medical device development and be exposed to clinical leaders who understand the needs behind the products you help to support.
What You Will Become: A capable technical teammate that supports our team as we drive excellence in document change management.
What Success Looks Like:
· Process and release ECR’s, ECOs, & MCO’s,
· Ensure the accuracy of change orders including but not limited to documentation, revisions, and required approvers.
· Proof read and edit completed documents for grammar, spelling, punctuation and adherence to appropriate formatting.
· Review approved documents for accurate format, signatures, dating and Good Documentation Practices (GDP).
· Manage the document approval process including final approval signatures, completed implementation.
· Support the LHR/DHR scanning for release in Agile.
· Support Agile releases to Learning Management System (LMS) for training.
Material and Equipment Directly Used:
· Computers with applicable software packages – Agile Product Lifecycle Management (PLM)
· Microsoft Office Suite
· Bachelor’s Degree or High School Diploma with relevant work experience
· Basic knowledge of Good Documentation Practices (GDP)
· 1-2 years’ experience working in a regulated industry or similar manufacturing and engineering environments preferred
· Highly organized and detail oriented with strong follow-up skills to manage large volumes of documentation. Ability to understand priorities.
· Excellent written and verbal communication skills.
· Accuracy is required in performing all functions of this position.
· Must demonstrate proficiency in computer skills and Microsoft Word, Excel and Visio, and Adobe Acrobat.
· Familiarity with Agile Product Lifecycle Management (PLM) system highly desirable
Thanks and Regards,
APN Software Services, Inc (www.apninc.com)
39899 Balentine Drive, Suite 385, Newark, CA 94560
Phone: 510-402-1080 / Fax 510-623-5055
Email Id: Sawant@apninc.com