Quality Assurance Specialist II
Quality Assurance Specialist II
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.
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.
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
- 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 I’s.
- Other duties as assigned.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Leadership qualifications include, among other requirements:
- Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
- 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.
- Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- Bachelor's Degree plus 3+ years of related experience in Quality Assurance.
- Basic knowledge of GMP regulations
- 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
- Ability to lift and transport up to 30 lbs
- Ability to work 1 weekend day (Schedule: Sunday-Thursday)
- Rotating 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.