Sr. QC Analyst, Cell Culture
Sr. QC Analyst, Cell Culture
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 cell culture maintenance and assays for incoming materials and validations
- 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.
- Perform finished product review and lot release.
- May manage departmental projects.
- May perform microbiological assays for in-process and final product samples.
- May troubleshoot assays and procedures when needed.
- Communicate inter-departmentally and with external 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.
- May transfer methodology from other groups.
- Other duties as assigned.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
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 5+ years, MS 3+ years of experience in a lab setting.
- 3+ years of experience in one or more of the following disciplines: microbiology, cell biology and cell culture, flow cytometry and/or molecular biology
- Experience as a technical leader in a strong team environment and work independently to successfully balance short and long term project objectives.
- 2+ years’ experience in a cGMP laboratory environment
- Experience with Deviation Management and Change Control.
- Experience with complex analytical methods such as PCR based methodology, microbiological testing, biological assays, or environmental monitoring.
- Experience using lab-based data management systems.
- 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.
- Rotating holiday coverage.
- 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.