GMP Document Reviewer
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 help biotech and pharma customers 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 that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
The Role
Under the direction of the Team Leader, the incumbent is responsible for reviewing, updating, tracking and providing timely processing of all assigned documentation generated or executed within the clinical Manufacturing Department.
As an Executed Batch Records (EBR) reviewer, this position is expected to conduct a full, comprehensive and complete EBR review on behalf of Clinical manufacturing group within 72 hours of batch documentation completion. EBRs consist of a stand-alone document or a combination of two or more GMP or non-GMP documents such as MBR, ETP, Cleaning Records, Validation/Tech transfer Protocols etc. With the guidance of the supervisor, the employee is expected to collect vital documented information on EBR errors, process improvement recommendations, feedback from operators, QA and the client to improve the overall quality and serviceability of the documents.
This position also supper scientist to write and issue Quality Investigations such as Deviation notification, and Variances based on project needs per discussion with Scientist or supervisor, and QA.
Main tasks and responsibilities will include:
- Review Clinical manufacturing EBRs.
- Review documents such as MBRs, ETPs, SOPs, and other supporting documentation such as protocols, reports for new and existing products as directed by supervisor.
- Address client comments and support comment resolution when needed.
- Adhere to Company Style Guide, templates, and SOPs for document development.
- Work with cross-functional teams to ensure production of high-quality executed and written documents.
- Under the guidance of the supervisor, establish priorities and deadlines for technical review & documentation.
- Train Clinical manufacturing team on GDP and other documentation as assigned.
- NLT 95% compliance at a minimum in all training required to conduct the job.
Additional Tasks/responsibilities
- Quality Tracking & Presentation skill.
- Clear Communication skill (Verbal and written).
The Candidate
- Associate or bachelor’s degree in English, health science or equivalent and at least 2 years of experience in reviewing of GMP documents in the pharmaceutical industry.
- Organized and capable of multi-tasking the roles of both EBR reviewer and other GMP documents for clinical team.
- Knowledge of pharmaceutical unit process for solid dosage form and GMP documentation process.
- Working knowledge of Quality Systems such as line clearance, logbook entries and other QA related activity preferred.
- Expert level of proficiency in MS Word, Excel (chart and graph display of data), and PowerPoint.
When applying for a position with Quotient Sciences you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient family and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.
Other details
- Pay Type Salary
- Boothwyn, PA, USA