Quality Assurance Specialist, I

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 and final product packaging/release to the courier.

ESSENTIAL FUNCTIONS

Core Responsibilities:

• Responsible for batch record documentation and for final batch disposition
• Support day to day operations, including: batch record and label issuance, archiving and verification

• Review and approve product and process deviations.
• Follow oral and written procedures for review and release of intermediate and final product.
• Participate in audits to ensure compliance to cGMPs and Vericel requirements.
• Identifies deficiencies and works with internal departments to remedy them.

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:

Preferred Qualifications:

• 1 year of GMP experience
• Strong written and verbal communication skills.
• Strong organization and time management skills.
• Proficient in MS Office suite.

Experience in a biotech, pharmaceutical or other regulated industry.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• Ability to lift and transport up to 30 lbs.
• Ability to work 1 weekend day.
• Rotating holiday coverage.

EEO Statement

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.