SQASC - 2018
US ~ Garnet Valley, PA
Senior QA Specialist - Clinical
Our growing and successful business comprises over 750 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. With our new clinical manufacturing site opening in Garnet Valley this fall, we are continuing to expand our presence in the contract research and manufacturing arena.
GENERAL PURPOSE OF ROLE
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 Sr 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following
- Review, provide input, and approve quality-related documents such as:
- raw material and finished product specifications
- analytical method qualification/validation protocols and reports
- stability study protocols and reports
- laboratory instrumentation IQ/OQ/PQ protocols and reports
- 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)
- Write and review procedures and other controlled documents as required
- Represent QA on internal project teams
- Become involved in site-wide compliance training initiatives
- Play active role during regulatory and client inspections
EDUCATION and EXPERIENCE
- Knowledge of science generally attained through studies resulting in a BS/MS Degree or equivalent preferably in Chemistry or Engineering
- A minimum of 9 years relative experience in Quality Control or Quality Assurance
OTHER SKILLS, ABILITIES OR 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
- Experience in solid dose manufacturing
- 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.