- Draft and revise 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 or lead the implementation of systems, 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).
- Operate in an environment of strict timelines.
- Oversee and or support the process of change control approval from evaluation of an initial proposal, through approval, implementation, closure and effectiveness review.
- Provide QA oversight of change controls to ensure that they meet the requirements of industry 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 quality management system electronic workflow.
- Apply and interpret industry 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.
- Monitor the status of open changes, providing periodic reports and status updates on the overall performance of the change control system.
- Assist with scheduling and 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 training of personnel, 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.
- 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 with 2+ years of relevant Quality/Compliance experience in a cGMP biotech or pharmaceutical regulated industry.
- Experience performing work that consistently requires independent decision making and the exercise of independent judgment and discretion in a cGMP environment.
- Experience writing and reviewing technical cGMP documents.
- A strong understanding of Medical Device and Biologics FDA regulations.
- Strong working knowledge of Trackwise or other quality management systems.
- Proven Risk Management/FMEA experience/knowledge.
- Good project management skills and working knowledge of statistical techniques.
- Experience serving as a Subject Matter Expert (SME) in regulatory inspections.
- Experience presenting in a group setting in areas of subject matter expertise.
- Experience influencing colleagues and management in a cross-functional environment.
- Strong written and verbal communication.
- Occasional overtime may be required for support of site inspections.
- Monday - Friday, Onsite
Quality Systems Engineer, II - Cambridge, United States - Vericel® Corporation
Description
Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing quality systems professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to the Lead, Quality Systems at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.
Department Description:
The Quality Systems (QS) Department manages Change Control, Design Control, Periodic Product Review, Inspection Readiness, Product Quality Reviews, Management Reviews and Risk Management. QS ensures compliance with company procedures and industry standards in support of cell therapy products.
Quality Systems Engineers are focused on the oversight of the Quality Systems that allow for efficient and compliant execution of operational projects. QS Engineers work closely with subject matter experts to facilitate the development and rapid adoption of value-added changes and processes, ensuring implementation in compliance with regulations, procedures and policies.
Position Summary:
The QS Engineer II 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 individuals throughout the facility.
ESSENTIAL FUNCTIONS
Essential Functions:
Key Functions may be in support of one or more of the following:
Change Control/Design Control
Risk Management
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Leadership Qualifications:
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:
Required Education and Experience:
Preferred Education and Experience:
WORKING CONDITIONS AND PHYSICAL DEMANDS