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.
Responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation.
- Perform maintenance on complex laboratory equipment.
- Participate in training of less experienced staff.
- Transfer methods from support groups to the QC laboratory.
- Coordinate departmental systems.
- Author protocols and technical reports related to the implementation of QC equipment.
- Communicate inter-departmentally and with outside contacts to solve technical issues.
- Exercise sound judgment and decision making when problem solving.
- Revise standard operating procedures as needed.
- Work in compliance with cGMPs.
- Practice safe work habits and adheres to Vericel's safety procedures and guidelines.
- Maintain lab documentation and notebooks, ensuring timely review, reconciliation, and filing.
- Perform deviation and lab investigations as needed.
- Master core responsibilities of an Analyst I.
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.
- Bachelor's degree or equivalent and 2-4 years of experience in a lab setting.
- Existing QC Analyst I demonstrating mastery of the QC Analyst II competencies.
- 1 year of experience in a cGMP lab environment.
- Proficient in Outlook, MS Word, Excel and lab based data management systems.
- Experience with microbiological testing, biological assays, or environmental monitoring.
- Experience in a biotech, pharmaceutical or other regulated industry.
- Excellent communication skills, verbal and non-verbal desired.
- Excellent technical writing and investigational skills.
- Experience with PCR based methodology or cell culture methods.
- Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.
- Ability to lift 40 lbs.
- Requires working one day per weekend.
- Rotating holiday coverage.
- Rotating off-shift alarm coverage. Must carry a company issued cell phone.
- Must be able to work Wednesday - Sunday from 7:00 am-5:00 pm.
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.