Quality Systems Specialist (Hybrid - Greater Philadelphia)
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- 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.
- To comply & adhere to Good Manufacturing Practice (GMP) standards.
Main Tasks and Responsbilities
- 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 compliance guidance to site staff.
- Author, review and approve reports, SOPs and protocols as needed.
- Support validation efforts. Review and approve IQ/OQ/PQ documentation.
- Perform internal and supplier audits and manage audit schedules
- Reviews and approves suppliers SCARs.
- Other duties as assigned
- May require occasional cross training both within and outside the Quality Assurance Department
- 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.
- 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 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.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.