Document Control Specialist, Senior
Document Control Specialist, Senior
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Document Control professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Supervisor, Document Control at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.
Work with primary originators of documentation to ensure that documentation is written, edited, reviewed, and approved in compliance with cGMP.
- Initiate QADC SOP improvements and execute document revisions through eWorkflow System.
- Develop and execute advanced training to QADC and external departments on Document Systems.
- Work as a team member and lead cross-functional project teams.
- Identify and facilitate department improvement projects.
- Ensure GMP documentation is correct, clear, and consistent.
- Provide advanced guidance to employees as needed.
- Participate in internal audits to ensure compliance to cGMPs.
- Support remediation efforts that are applicable to documentation.
- Facilitate the Document Periodic Review Program.
- Prepare and manage data to be archived to off-site storage facility.
- Perform data entry for tracking documents and departmental metrics.
- Maintain controlled documents in strict compliance to corporate policies and regulations.
- Facilitate the effective processing of Quality System documents to ensure they are maintained and archived in an organized and retrievable state for accountability and access for any regulatory body.
- Conduct investigations and change controls as applicable.
- Other duties as assigned.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
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.
- High School degree or equivalent and 7+ years of related experience, or
- Associates degree or equivalent and 5+ years of related experience
- 2-4 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
- Extensive experience with working in a Document Management System (i.e. Livelink, Documentum, etc.)
- Quality Management System (Deviations, CCRs, etc.) experience
- 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.