Department: Quality Systems
The Quality Systems Department manages Change Control, Product Quality Reviews, Management Reviews and Risk Management. QS ensures compliance with company procedures and industry standards in support of cell therapies products. Staff works closely with subject matter experts to facilitate the development and rapid adoption of value-added changes and processes, ensuring implementation is compliant with regulations, procedures and policies.
This individual will assist in ensuring that quality systems are in place and cGMP compliance is maintained. Work and decisions will be based on a collaborative culture with Manufacturing, Engineering, Facilities and Validations.
- Support revision of procedures as required to ensure that documentation and operations meet established requirements of regulations, cGMPs, and internal SOPs and company policies.
- Apply and maintain quality standards and procedures for quality systems.
- Review executed cGMP documents and participate in the implementation of systems for the acquisition, processing and storage of cGMP information.
- Monitor the status of assigned quality system(s), providing periodic reports and status updates on the overall performance of the quality system(s).
Key Functions may be in support of one or more of the following:
- Support the process of change control approval from evaluation of an initial proposal through approval, implementation, closure and effectiveness review.
- Provide QA support of change controls to ensure that they meet the requirements of Vericel standards and procedures, and are clearly written and appropriately justified. Provide QA approval of those changes at various points in the change life cycle, utilizing a Trackwise electronic workflow.
- Apply and interpret Vericel corporate standards and local procedures governing the change control process to proposed changes, consulting with QA management as appropriate. Work with project teams to determine the change control approach for projects.
- Verify the completeness and correctness of supporting documentation for changes, including items such as engineering studies, validation protocols, technical reports, engineering drawings and SOP changes. May also serve as the QA approver for this supporting documentation.
- Assist in the management of the Design Control program, updates to Design History Files, and participate as a Quality representative in the design review process.
- Monitor the status of open changes, providing periodic reports and status updates on the overall performance of the change control system.
- Assist with driving activities of the risk management program with respect to scheduling meetings, developing quality documentation and data management.
- Help ensure that manufacturing sites comply with the requirements of the risk management program and complete assessments and reports in a timely manner according to regulations, procedures and policies.
- Participate in the risk assessment process as it relates to assisting with categorizing risk and assigning report numbers.
- Provide clear and concise reports of risk management activities/ assignments throughout the site and provide key metrics that monitor compliance for the risk management program.
Electronic Quality Systems (e.g. Trackwise)
- Participate in implementation of systems for the acquisition, processing and storage of cGMP information.
- Provide QA review of deviations, CAPA, complaints and maintenance activities to ensure that they meet the requirements of Vericel standards and procedures, and are clearly written and appropriately justified.
- Provide QA approval of deviations, CAPA, complaints and maintenance activities as necessary, and at times utilizing an electronic workflow.
- Monitors and reports on status of quality data and systems with a view to ensure timely completion of compliance activities and awareness across involved departments and management.
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 in Science or Engineering with 1-2 years of cGMP experience.
- Prior experience working in a Quality/Compliance role within the pharmaceutical or medical device industry.
- Experience writing and reviewing technical cGMP documents.
- Experience with an electronic Quality/Document Management System.
- Strong written and verbal communication.
- Experience operating in an environment with strict timelines.
- Advanced proficiency in basic Microsoft Office applications: Word, Excel, PowerPoint
- Familiarity with advanced Microsoft Office applications: Visio, Project, Access.
Familiarity with one or more of the following areas :
- Biopharmaceutical process equipment.
- Cell Culture or Protein Purification processes.
- Media and Buffer Manufacturing processes.
- QC test equipment and methods.
- ISO classified environments and environmental monitoring programs.
- Critical utilities such as WFI, purified water, clean steam and HVAC and other critical utility systems; ISO classified environments.
- Knowledge of regulations and standards affecting Pharmaceuticals, Biologics, and/ or Medical Devices.
- Experience performing work that consistently requires independent decision making and the exercise of independent judgment and discretion in a cGMP environment.
- Experience presenting in a group setting in areas of subject matter expertise.
- Experience influencing colleagues and management in a cross-functional environment.
- Experience with GMP/GLP standards and regulatory guidance documents, and the FDA QS regulation.
- Experience serving as Subject Matter Expert (SME) in regulatory inspections.
- Working knowledge of Trackwise a plus.
- Good project management skills are desired and a working knowledge of statistical techniques.
- Good presentation skills, excellent written and verbal skills. Experience with project management or project team leadership.
- Experience generating process metrics and reports.
- Knowledge of Statistical Process Controls (SPC).
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.