Quality Control (QC) is responsible for incoming inspection of components and raw materials, plus quality testing (e.g. analytical, microbiological) of intermediate, stability and final product samples to demonstrate that all products manufactured meet standards required for cGMP operations. Various techniques (e.g. assay transfers, validation and qualification of new instrumentation) are utilized within the Quality Control Laboratory to ensure cGMP compliance.
This position will support all QC materials operations for approved and clinical trial cell therapy products in a fast paced GMP customer service based environment.
- Inspection, sampling, and release/rejection of components and raw materials as per SOP's and specifications.
- Individual will monitor various stages of processing along with the appropriate paperwork in compliance with specifications.
- Frequent interaction with internal departments and outside vendors when required.
- Performing inventory cycle counts.
- Conducting monthly walk-through audits.
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.
- High school diploma or equivalent and 1+ years of experience.
- Direct work experience in a cGMP and pharmaceutical/medical device quality inspector system.
- Excellent communication skills both written and verbal.
- Effective time management, multitasking and organizational skills.
- Strong attention to detail and cross functional team experience.
- Computer skills in systems such as Microsoft Word and web based software programs.
Working Conditions and Physical Demands:
- The position will be based at 64 Sidney St in Cambridge, MA but will also be based in Pepperell, MA.
- Travel (1-2x/week) between Cambridge and Pepperell, MA required.
- Personal transportation required.
All qualified 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 Employer