Quality Control Specialist
Quality Control Specialist
This position in the Vericel Quality Control Department is responsible for coordination, completion and management of all process related documentation, which includes investigations, deviations, CAPAs, LIRs, change controls and improvement initiatives. The focus of the position is to lead investigations, respond to and drive audit commitments controls and implement procedural improvements within associated timelines. Decisions will be based on a collaborative culture with Manufacturing, Validation, Regulatory, Quality Assurance, Quality Systems, Quality Control, Engineering, Facilities, and Research and Development. In the course of their duties, this position will manage multiple projects concurrently.
Core Responsibilities of this position include, but are not limited to:
- Daily management of compliance commitments including driving the implementation of internal commitments, leading deviation investigations, and working cross functionally to support on time release of product.
- Coordinate, compile and present all metric data for Quality Control.
- Coordinate, compile and write all Environmental Monitoring Reports.
- Lead and manage quality project assignments through the Change Control and Risk Assessment process from evaluation of an initial proposal through approval, implementation, closure and effectiveness review.
- Monitor project progress for intervention and problem solving with quality project teams to determine technical leaders, when required, status of open changes and associated tasks by providing periodic reports and progress updates.
- Responds timely to compliance concerns and oversees problem resolution to completion. Manages multiple compliance projects, realigning resources and priorities to meet challenging timeframes.
- Assist with the progress of Trackwise deviations and CAPA management for applicable process deviations with the quality team and cross functional colleagues in Manufacturing and RA on investigations, root cause analysis and resolution.
- Perform RCA, analyst interviews, impact assessments, and data gathering for Trackwise events.
- Lead and manage all Laboratory Investigations; requesting assistance from internal teams when necessary.
- Performing Effectiveness Reviews for CAPAs implemented.
- Communicate and interface with internal and external customers, including audit agencies, when required.
- Proactively seeks to affect change to provide an inspection readiness state and reduce the number of observations identified during audits/inspections conducted.
An ongoing commitment to conducting our 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 in a scientific or related field and 2+ years of related experience
- Proficient in Microsoft Office
- Familiar with cGMP processes
- Ability to present technical data
- Ability to work independently on projects
- Experience writing Standard Operating Procedures.
- Scientific technical writing ability including authoring and writing technical reports
- Quality Control experience in GMP environment including previous experience with environmental monitoring, troubleshooting of assay and equipment issues
- Experience working on cross functional teams.
- Strong written and verbal communication skills.
- Experience within a regulated environment that is frequently audited by FDA and other internal and external Agencies.
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.