CM - 21 - 58
US ~ Garnet Valley, PA
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.
As an Executed Batch Records (EBR) reviewer, this position is expected to conduct a full, comprehensive and complete EBR review on behalf of Commercial 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.
As a Technical Writer, this position will issue Quality Investigations such as Deviation notification, and Variances based on discussion with supervisor, Commercial manufacturing team and QA. The core work will also include technical writing such as (but not limited to) protocols, reports, memorandum, quality incidents and their investigations, APR, MBR and other regulatory documentation to be completed in a timely manner, and their proper disposition and retrieval whenever needed.
Main tasks and responsibilities will include:
- Review Commercial EBRs.
- Write / edit / review documents such as MBRs, ETPs, SOPs, and other supporting documentation such as protocols, reports for new and commercial 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.
- Use experience in Process Development to identify technical inconsistencies and participate in resolution.
- Perform other related duties and assignments as required.
- Write SOPs and performance goals to ensure they reflect a commitment to quality and efficiency.
- NLT 95% compliance at a minimum in all training required to conduct the job.
- Perform other duties as assigned.
- 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.
- Attend client meetings and generate orderly meeting timelines.
- Associate or bachelor’s degree in English, health science or equivalent and at least 5 years of experience in writing and editing regulated documents in the pharmaceutical industry.
- Organized and capable of multi-tasking the roles of both EBR reviewer and Technical writer smoothly.
- Scientific background demonstrated experience in writing and understanding of regulatory process for writing is required.
- Experience reviewing GMP documents, and interpreting study data/reports.
- Ability to work with large data sets.
- Expert level of proficiency in MS Word, Excel (chart and graph display of data), and PowerPoint.
- Excellent working knowledge of Quality Systems such as Deviation Investigations, CAPAs, Change Controls, etc.
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.