Document Specialist II

Document Specialist II

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing document control professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Manager, Document Control at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.

POSITION SUMMARY

Department Description:

Processes and controls documentation as required by GxP Regulations.

Position Summary:

Work with primary originators of documentation to ensure that documentation is written, edited, reviewed, and approved in a timely manner to meet established deadlines.

Core Responsibilities:

• Process Documents and associated historical data
• Ensure GxP documentation is correct, clear, and consistent.
• Finalize controlled documents in the Electronic Document Management System (eDMS) and maintain / distribute Official Copies.
• Contribute to / identify department improvement projects.
• Contribute to QADC document improvements and execute document updates through eDMS.
• Update and maintain workflows and various databases.
• Provide guidance to employees as needed.
• Ensure document formatting requirements are adhered to per departmental procedures.
• Perform data entry for tracking documents and departmental metrics.
• Develop and execute training to QADC and external departments on Document Systems.
• Prepare and manage data to be archived to off-site storage facility.
• Facilitate the Document Periodic Review Program.
• Maintain controlled documents in strict compliance to corporate policies and regulations.
• Facilitate the effective processing of Quality Systems documents to ensure they are maintained and archived in an organized and retrievable state for accountability and access for any regulatory body.
• Other duties as required.

Leadership qualifications include, among other requirements:

• Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
• Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

• High School Diploma or equivalent and 5+ years of related experience, or
• Associates degree or equivalent and 3+ years of related experience
• 2 years of GMP document control experience
• 1-2 years of MS Office Suite experience; MS Word - ability to create / modify templates, knowledgeable with styles formatting, and track changes functionality;
  MS Excel - ability to generate spreadsheets with applied knowledge of formula creation and maintenance, charting, and formatting
• Strong written and oral communication skills
• Time management skills
• Strong attention to detail

Preferred Qualifications:

• College degree or equivalent in related field
• Familiarity with working in a Document Management System (i.e. Veeva Vault QualityDocs, etc.)
• Technical writing experience

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Ability to lift and carry up to 15 lbs
• May require holiday coverage

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