Quality Systems Engineer II
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.
- 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.
- 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.
QUALIFICATIONS, EDUCATION AND EXPERIENCE:
- 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.