SQE - 2019
US ~ Boothwyn, PA
Senior Quality Engineer
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
Due to growth and expansion, we have an exciting opportunity for a Senior Quality Engineer to join Quotient Sciences, Philadelphia. In this role, you will be responsible for working across functions to assure the controls necessary to consistently deliver high quality product are established, maintained, and continuously improved. This position will champion timely quality issue resolution with a strong focus on root cause identification and effective corrective action implementation to mitigate recurrence of issues, process controls and capabilities to reduce variability in manufacturing and prevent quality issues, risk assessment and mitigation, and continuous improvement projects focused on product quality. This position serves as a role model for the behaviors necessary to maintain compliant GMP practices in a regulatory environment and advance the quality culture.
Other tasks and responsibilities will include:
- Identify appropriate statistical sampling plans and methods to assure critical process parameters (CPPs) impacting critical to quality attributes (CQAs) are adequately defined. Ensure there are adequate product and process controls in place for identified CPPs and CQAs in order to prevent product quality defects. Develop and maintain Control Plans that define these controls.
- Collaborate with Manufacturing and Technical Operations to complete process risk assessment (FMEA). Identify and drive implementation of continuous improvement activities to control risks at acceptable levels and prevent quality issues.
- Lead and participate in thorough investigations of quality issues and assure timely resolution. Use root cause investigation tools, such as Five Whys or Ishikawa, to assure the true root cause of problems are identified. Identify and implement sustainable corrective actions that effectively correct the root cause(s). Ensure investigation and CAPA records are complete, thorough, accurate and timely.
- As part of each investigation, facilitate the information gathering from all necessary internal and external sources and assess impact of issue to work-in-process (WIP) and previously manufactured products. Identify containment actions necessary to mitigate risk.
- Gather, analyze and apply information from internal and external sources to perform an assessment of risk for deviations and customer complaints.
- Track, trend and analyze product quality data using statistical and non-statistical tools to identify adverse trends and implement actions to mitigate. Prepare accurate and timely metric reports for management.
- Using industry standards, identify preventive actions and continuous improvements necessary to prevent product quality defects. Assure alignment with senior management and lead implementation of actions.
- Provide Quality Engineering support and technical guidance to manufacturing and quality control to solve complex problems.
- Assure procedures related to investigations, CAPA, statistical techniques, and data analysis and trending are maintained in compliance with regulatory expectations and industry best practices.
- Participate in the site’s internal audits to assess the site’s state of compliance. Identify gaps and work with area leaders to correct identified gaps in a timely and efficient manner.
- Prepare and deliver cGMP training to ensure site personnel maintain the required competency and thorough understanding of effective and compliant QMS execution. Design training to include Knowledge Assessments to measure effectiveness of training.
- Demonstrate Lean behaviors by actively working towards continuous improvement, and consistent and simplified ways of working.
- Perform other duties as assigned.
The candidate must have:
- Bachelor’s degree in a technical discipline with minimum of 5 years of experience in pharmaceutical quality with broad knowledge of cGMPs and quality systems
- Strong analytical and problem solving skills
- Effective interpersonal skills with a special focus to customer satisfaction
- Certified Quality Engineer (CQE), or Six Sigma Certification preferred
Other essential skills and experience are:
- Must have experience with cGMP pharmaceutical manufacturing, quality, and compliance;
- Strong knowledge of statistical techniques, process capability, risk assessment and root cause investigation;
- Solid understanding of LEAN and six sigma principles;
- Ability to apply critical thinking and deductive reasoning to identify and address quality opportunities to improve overall system effectiveness;
- Ability to effectively work and communicate (written and verbal) with other departments and personnel at all levels within the organization;
- Strong technical writing, ability to provide guidance to others in technical writing and ability to write and review technical reports with clarity and brevity;
- Must be time organized and self-directed;
- Recognizes risks and mitigates accordingly;
- Able to produce reports and metrics with precision;
- Successfully completes regulatory and job training requirements.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.