US ~ Boothwyn, PA
Quality Systems Specialist
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, specializing 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 Quality Systems Specialist to join Quotient Sciences, Philadelphia. In this role, you will be responsible for administering the site’s Quality Management System and assuring its continued compliance with applicable global regulations, standards, and global company policies and procedures. This position will execute and maintain quality systems including, but are not limited to, investigations, change control, CAPA, auditing, risk management, vendor quality management, and validation. 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.
The candidate must have:
- Bachelor’s degree in a related discipline with minimum of 4 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
Other essential skills and experience are:
- Must have experience with cGMP pharmaceutical manufacturing, quality, and compliance;
- Ability to identify and address quality opportunities to improve overall system effectiveness;
- Ability to effectively work 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
Main tasks and responsibilities
- Determine when a quality issue report needs to be initiated and collaborate with the initiator to assure an accurate and comprehensive problem statement is written.
- Continually assess the timeliness of the site’s resolution of quality issues, investigations, and corrective and preventive actions. Proactively work with document owners to prevent documents from becoming past due by identifying effective actions to close the records within timeframes defined in procedures. Collaborate with document owners to resolve any records that are overdue.
- Review completed investigations to assure impact assessment is appropriate, the root cause is identified and the corrective actions are appropriate and commensurate with risk.
- Maintain compliant, efficient and effective quality system procedures for the site. Revise documents as industry regulations, standards and best-practices change to assure procedures remain current.
- Lead and 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.
- Review the site’s change control plans and completed change control packages to assure changes are properly managed, verified and/or validated as necessary prior to implementation.
- Maintain the site’s risk registry and assure risk assessments are conducted to identify, analyze, reduce, as required, and control risks in a timely manner to ensure product quality and support business and compliance needs.
- Own the site’s Validation Master Plan. Review qualification and validation protocols and reports to assure they are complete, accurate, comply with company procedures. Assure validation activities result in processes that operate in a state of control.
- Participate in activities to evaluate new and existing site suppliers/subcontractors in accordance with the company’s supplier management program including supplier audits and the preparation of Quality Agreements. As required, collaborate with suppliers to resolve quality issues and escalate issues with strategic/global suppliers to Global Supplier Quality Management.
- Prepare accurate and timely metric reports for management. Analyze data to identify adverse trends and implement actions to mitigate.
- Prepare and deliver GxP 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.
In return you will receive a competitive salary, a generous benefits package, as well as an exciting career within a fast paced and dynamic business.