Document Specialist II
Document Specialist II
Work with primary originators of documentation to ensure that documentation is written, edited, reviewed, and approved in compliance with cGMP
- Process Document Change Requests (DCRs) and documentation status reports.
- Finalize controlled documents (masters) and maintain / distribute Official Copies.
- Contribute to (and occasionally identify) department improvement projects.
- Contribute to QADC SOP improvements and execute document revisions through eWorkflow System.
- Ensure GMP documentation is correct, clear, and consistent.
- 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.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- 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.
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- HS diploma or equivalent and 5+ years of 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, hyperlinking 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. Livelink, Documentum, etc.)
- Technical writing experience
Working Conditions and Physical Demands:
- Ability to lift and carry up to 40 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.