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 senior level laboratory tasks including performing routine and complex testing of in-process, raw material and final products samples in accordance with SOPs for product release and validation.
- Perform QC testing in a cGMP lab for raw materials release, final product/in process testing and process qualifications.
- Environmental monitoring ,sterility testing, foreign matter testing, water, dual stain, LAL, pH.
- Conduct data analysis of testing results, and review data obtained for compliance to SOP and specification.
- May participate in the transfer methodology from other groups and may maintain complex equipment.
- Provide training and technical leadership to less experienced staff.
- Participate in laboratory investigations.
- Oversee day to day laboratory systems which include inventory/ordering; test record maintenance, logbooks, sample reconciliation, equipment maintenance, etc.
- May oversee special studies (R/D, Validation) to ensure testing is completed as required.
- Perform finished product review and lot release.
- Schedule laboratory activities in collaboration with the Manager.
- Practice safe work habits and adheres to company safety procedures and guidelines.
- Serve as the point of contact for less experienced staff when management is not present (ex. weekends, holidays)
- Master core responsibilities of an Analyst II.
The Senior QC Analyst Laboratory may participate in investigations, CAPA, change controls, scheduling, project management, author reports and other documentation (Protocols, SOPs) for quality testing as applicable.
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 in a scientific discipline and 6 +years of cGMP quality experience, or comparable laboratory experience.
- Existing QC analyst II demonstrating mastery of the Analyst Senior competencies.
- Must have experience as a technical leader in a strong team environment and work independently to successfully balance short and long term objectives.
- Experience with complex analytical methods. E.g. PCR based methodology, Microbiology 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.
- Advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods, etc.
Special Working Conditions:
- Ability to lift 40 lbs.
- Requires working one day per weekend.
- Rotating holiday coverage.
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 Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.