Report Writer

Job description

Report Writer

Your Role:

As Report Writer you will be part of the Process Solutions Services team that designs and delivers Viral Clearance validation studies for biopharmaceutical companies across the APAC region. The Report Writer is responsible for the preparation of Final Reports and Certificates of Analysis using data obtained from GLP/GMP assays performed across all Bioreliance Biotesting Lab in Singapore.  In collaboration with the laboratory personnel, the Report Writer summarizes the life cycle, technical processes and assay results of a sample in a Final Report. The Report Writer will work closely with the Study Directors to prepare the study file and generate the final report on time. The Report Writer will review batch records, process data and perform trend analysis data to ensure consistent assay performance and scientific integrity of the study.

 

The post holder needs to have an understanding of technical/ scientific observations and ensure all documentation generated fulfils quality and regulatory standards and practices (GLP or GMP) as well as client specific requirements when reporting assays. The post holder will be proficient in generating reports in English and is able to translate to Mandarin report when required for clients for regulatory filing with respective local regulatory government.

 

Brief role description:

·  Summarizes technical data into a high-quality report or certificate of analysis as required, in a timely manner
·  Is familiar with study-specific protocols, technical specifications, applicable SOPs and regulatory requirements
·  Prepares study reports and any applicable study associated Final Report/Certificate of Analysis amendments according to specific client requests to achieve on time delivery.  Address comments on these study reports following Study Director review and Quality Assurance audit
·  Generate, control and tracking of revisions to all appropriate Report/Certificate templates
·  Translates reports written in English to Mandarin when required
·  Progresses CAPA and change controls associated with any aspect of the technical writer function, ensuring records are closed in accordance with the assigned timelines
·  Ensures a safe and healthy work environment at all times by not only complying with but actively embracing health and safety policies and procedures, ensuring the safety of yourself and others within the workplace
·  Review Right First Time (RFT) metrics with the appropriate personnel in order to drive down error rates.
·  Input dates into Information management systems and prepare study files for archiving
·  Reviews laboratory records and performs statistical analysis to calculate virus titers log reduction factions
·  Provides hands-on support to the lab team by performing virus titration assays, virus infectivity reads and virus titre calculations when required
·  Performs trend analysis to ensure the assay remains in the qualified state of control
·  Prepares system reports in support of huddles and metrics tracking

 

Who You Are:
 

·  Master/Bachelor in Biology/Biological Sciences/Life Sciences or higher degree in relevant scientific subject
·  Minimum 1-2 years of experience in a scientific laboratory role
·  Previous experience in scientific writing
·  Previous experience working in a regulated environment (GLP/GMP) would be advantageous
·  Adheres to SOPs and protocols, and ensures compliance to site policies and regulations
·  Proficient in written Chinese with demonstrated capability to translate scientific document from English to Mandarin for clients for filing with respective local regulatory government
·  Computer literacy and entry of data into databases (LIMS, ELN, SAP, etc.)
·  Ability to complete documentation (both handwritten and electronic) clearly and accurately

Job Requisition ID: 198512

Location: Singapore

Career Level: C - Professional (1-3 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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