Quality Assurance Specialist II

Company: Vericel
Location: Cambridge
Posted on: June 10, 2021

Job Description:

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 compliance improvements.
• 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 corrective actions.
• Support the training of specialist Is.
• 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 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.

Basic Qualifications:

• High School Diploma plus 3+ years of related experience in Quality Assurance.
• 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 (Trackwise)
• Proficient in MS Word, Excel, and PowerPoint

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Able to lift and transport up to 40 lbs
• Must work 1 weekend day (Schedule: Tuesday-Saturday)
• Rotating holiday coverage.

Keywords: Vericel, Cambridge , Quality Assurance Specialist II, Other , Cambridge, Massachusetts