QADIS - 2018
US ~ Boothwyn, PA
QA Data Integrity 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, 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.
We have a great opportunity at our Philadelphia, USA sites for a QA Specialist role with special focus on data integrity and risk management. This role will be responsible to plan, implement and coordinate quality assurance programs to prevent or minimize quality risks including that to the integrity of data at the Philadelphia GMP manufacturing sites. The role will provide independent oversight to the Quality Risk Management (QRM) and data integrity programs for the facilities.. This individual will work in a detail oriented, compliant manner to ensure the facility operations align with Quotient Sciences policies and procedures as well as cGMPs and industry expectations.
This is an excellent opportunity for someone who is looking to use their technical and compliance training to work in a challenging clinical and commercial environment supporting a cross functional team.
Other tasks and responsibilities will include:
As the QA Specialist, this role will:
- Represent the site Quality Assurance department as SME in Data Integrity.
- Manage risk register and associated activities.
- Perform Data Integrity risk assessment of GMP systems both manual and automated.
- Prioritize risks and work with IT, QA, Laboratory, Manufacturing and warehouse personnel to mitigate Data Integrity gaps.
- Be current with regulatory requirements (FDA, EMA, MHRA) and applicable regulations related to Data Integrity.
- Represent Quotient Sciences in client and regulatory audits related to Data Integrity.
- Establish a firm understanding of Quotient Sciences’ IT Infrastructure, assesses proposed changes for Data integrity implications, and recommends infrastructure changes to enhance Data Integrity.
- Evaluate proposed and existing software systems that support manufacturing, warehousing and laboratory and also software applications for Data Integrity gaps. Works with IT and QA to resolve those gaps.
- Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines and fulfill client and Quotient Sciences requirements.
- Support stakeholders in mitigating risk.
- Bachelor’s degree (or equivalent) required in a relevant scientific discipline
- Relevant industry experience (6+ years) including strong knowledge in GMP regulations working in a pharmaceutical, biotechnology or medical device industry
- Demonstrated experience providing customer-related QA services preferably in a contract services environment
- Possess or working towards a Certified Quality Auditor designation or be certified/registered in another recognized/relevant organization (desired)
- Thorough working knowledge of 21CFR Parts 210, 211, 11/ Annex 11, ICH Q9,Q10, E6, GAMP5,ISO 14971 and all applicable regulatory requirements
- Experience working with Information Technology and a fundamental understanding of IT concepts preferred.
- 3+ years of experience in a computer systems validation or quality assurance role
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.