US ~ Garnet Valley, PA
GMP Document Reviewer
Our growing and successful business comprises of over 900 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.
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.
- Quality Tracking & Presentation skill.
- Clear Communication skill (Verbal and written).
The job involves the following:
- Very high concentration of work at times and at regular intervals.
- Strict and tight agreed upon deadlines.
- Having to juggle a range of tasks/issues simultaneously.
- Working outside normal working hours.
- Needing to respond to client demands.
- Organizational skills.
- Strong Computer skills.
- Ability to work with others in a team environment.
- Attention to detail.
- 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.
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.