QAS -1 - 2019
US ~ Boothwyn, PA
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.
The Senior QA Specialist will represent Quotient Sciences QA on projects providing pharmaceutical development support to our clients. The majority of projects will involve oral solid dosage pharmaceutical products in various stages of development, from pre-formulation through validation. The Senior QA Specialist will support these projects by communicating compliance requirements and ensuring company adherence to current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), applicable regulatory standards, and internal procedures and practices.
Other tasks and responsibilities will include:
- Review, provide input, and approve quality-related documents such as:
- processing equipment qualification protocols and reports (IQ/OQ/PQ)
- environmental monitoring procedures, methods, results, and reports
- manufacturing batch records and associated documentation
- risk assessment reports for cross-contamination
- instrument and equipment impact assessment reports
- analytical test results, and raw data supporting test reports such as laboratory notebooks and chromatographs
- Understand and ensure that the team meets applicable regulatory requirements in drug development (21CFR210, 211, 11 and ICH guidelines as well as Eudralex)
- Lead QA activities and participate on Quotient teams supporting customer projects
- Become involved in site-wide compliance training initiatives
- Play active role during regulatory and client inspections
- Knowledge of science generally attained through studies resulting in a BS/MS Degree or equivalent preferably in Chemical Engineering, Chemistry, or Industrial Pharmacy
- A minimum of 3-5 years relative experience in Quality Engineering or Quality Assurance
Other Skills, Abilities, and Qualifications
- Working knowledge of current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), and other data-integrity-related regulatory requirements.
- Solid understanding of analytical chemistry and instrumental analysis. Proficiency and problem-solving skills with HPLC, GC, LC-MS and other chromatographic techniques. Familiarity with spectroscopic techniques is an advantage.
- Knowledge of Quality by Design principles is a plus
- Understanding of US and EU Good Manufacturing Practices
- Careful attention to detail and strong organizational skills
- Experience in solid dose manufacturing
- Member of ISPE preferred
- Microsoft Office (Word, Excel, Outlook, and PowerPoint).
- Ability to work in a fast-paced environment, to multi-task, and to work with others as a team.
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.