QC Analyst II
QC Analyst 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 Control 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 Senior Manager, QC Microbiology 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.
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 current Good Manufacturing Practices (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 microbiological assays for in-process and final product samples.
- Perform analytical methods for final bulk material/finished goods.
- Perform maintenance on complex laboratory equipment.
- Participate in training of less experienced staff.
- Participate in transfer methods from support groups to the QC laboratory.
- May perform finished product review and lot release.
- Coordinate departmental systems (i.e. inventory, documentation, equipment maintenance)
- 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.
- Perform deviation and lab investigations as needed.
- Master core responsibilities of a QC Analyst I.
- 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 or equivalent and 3+ years, MS with 0-1+ years of experience in a lab setting.
- 2+ years of experience in one or more of the following disciplines: microbiology, cell biology and cell culture, flow cytometry and/or molecular biology
- 1+ years of experience in a cGMP lab environment.
- Proficient in Outlook, MS Word, Excel and lab-based data management systems.
- Experience with environmental monitoring in a clean room environment.
- Experience in a biotech, pharmaceutical or other regulated industry.
- Excellent communication skills, verbal and non-verbal desired.
- Excellent technical writing and investigational skills.
- Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.
WORKING CONDITIONS AND PHYSICAL DEMANDS
- Ability to lift 40 lbs.
- Requires working one day per weekend.
- Rotating holiday coverage.
- May carry a company issued cell phone for rotating off-shift alarm coverage.
- May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
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.