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.
Processes and controls documentation as required by GxP Regulations.
Work with primary originators of documentation to ensure that documentation is written, edited, reviewed, and approved in a timely manner to meet established deadlines.
- 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.
- 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
- 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
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.