QC Analyst II, Cell Culture
QC Analyst II, 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 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.
- 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 an Analyst I.
- Other duties as assigned.
- Bachelor's degree or equivalent and 2+ years of experience in a lab setting.
- 2+ years of experience with primary cells and cell culture
- 1 year of experience in flow cytometry and/or molecular biology
- 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.
Working Conditions and Physical Demands:
- Ability to lift 40 lbs.
- Schedule is Sunday - Thursday, 8 AM - 4:30 PM
- Rotating holiday coverage.
- Rotating off-shift alarm coverage. Must carry a company issued cell phone.
- 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.