Cambridge, England, gb Life, Physical, and Social Science Occupations
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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 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 QC testing in a cGMP lab for raw material release, final product/in process testing and process qualifications
Conduct data analysis of testing results, and review data obtained for compliance to SOP and specification.
May transfer methodology from other groups and may maintain complex equipment.
Author reports, SOPs and other documentation for quality testing.
Provide training and technical leadership to less experienced staff.
Participate in and/or perform laboratory investigations and non-conformance deviations.
Perform finished product review and lot release.
Manage departmental projects.
Serve as the laboratory point of contact for less experienced staff when management is not present (weekends, holidays)
Participate in the execution of corrective and preventative action plans as well as the initiation and follow through for change controls.
Author protocols and technical reports related to the implementation of QC equipment.
Master core responsibilities of an Analyst II.
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 the company 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 4 +years of experience in a lab setting.
Experience as a technical leader in a strong team environment and work independently to successfully balance short and long term project objectives.
Experience with Deviation Management and Change Control.
Experience with complex analytical methods such as PCR based methodology or cell culture methods.
Experience with assay/equipment validations/transfers.
Experience with microbiological testing or environmental monitoring.
Excellent communication skills, verbal and non-verbal desired.
Excellent technical writing and investigational skills.
Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.