Document Control Specialist I
Company: Vericel Corporation
Posted on: November 22, 2021
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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. POSITION SUMMARY Work
with primary originators of documentation to ensure that
documentation is written, edited, reviewed, and approved in
compliance with cGMP. ESSENTIAL FUNCTIONS
- 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
- Identify and facilitate department improvement projects.
- Ensure GMP documentation is correct, clear, and
- Provide advanced guidance to employees as needed.
- Participate in internal audits to ensure compliance to
- Support remediation efforts that are applicable to
- Facilitate the Document Periodic Review Program.
- Prepare and manage data to be archived to off-site storage
- Perform data entry for tracking documents and departmental
- 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
- Conduct investigations and change controls as applicable.
- Other duties as assigned. QUALIFICATIONS, EDUCATION AND
EXPERIENCE Leadership Qualifications: An ongoing commitment to
conducting business according to the highest legal and ethical
standards, and to continually pursue excellence in the development
and delivery 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
- Constantly striving to make Vericel a great place to work, and
a company respected for the quality of its people and products.
- High School degree or equivalent and 7+ years of related
- Associates degree or equivalent and 5+ years of related
- 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
- Strong attention to detail Preferred Qualifications:
- 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.)
Keywords: Vericel Corporation, Cambridge , Document Control Specialist I, Other , Cambridge, Massachusetts
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