Quality Assurance Specialist II
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 Quality Assurance 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 Manager,
Quality Operations 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
Department Description: The Quality Assurance department ensures
that the site operates at a high level of compliance and ensures
quality decisions are being made in accordance with regulatory and
site requirements. Position Summary: This position is responsible
for operational support, including batch record review, media
disposition, label issuance and reconciliation, archiving, final
product packaging/release to the courier, customer complaint
audits, write and/or revise standard operating procedures ESSENTIAL
FUNCTIONS Core Responsibilities:
- Master core responsibilities of Specialist I.
- Maintaining and adhering to compliance requirements for
established quality systems programs.
- Identify issues, provide recommendations as well as executing
- Participate in mid-scale projects or assignments.
- Address and/or escalate compliance problems and issues.
- Interact with project teams and applicable research groups as
they impact the quality operation.
- Product complaints: independently receive, review, audit
accompanying patient file, and send to Customer Care.
- Independently initiate QA deviations and perform
investigations, including determining root cause and planning
- Support the training of specialist I's.
- Other duties as assigned. QUALIFICATIONS, EDUCATION AND
EXPERIENCE Leadership Qualifications: 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
- 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
- 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. Basic Qualifications:
- High School Diploma plus 3+ years of related experience in
- Basic knowledge of GMP regulations Preferred Qualifications:
- Strong written and verbal communication skills
- Strong organization and time management skills
- Experience with Electronic Quality Management Systems
- Proficient in MS Word, Excel, and PowerPoint WORKING CONDITIONS
AND PHYSICAL DEMANDS
- Able to lift and transport up to 40 lbs
Keywords: Vericel Corporation, Cambridge , Quality Assurance Specialist II, Other , Cambridge, Massachusetts
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