Loading...
Share this Job
Apply now »

Quality Assurance Specialist

We are a leading science and technology company. Our life science business offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.

 

Your role:

Quality Assurance Specialist is to promote and integrate quality into every aspect of our BioReliance biologics safety testing business in Singapore. The role is to perform batch record review (i.e. data audits) to support all aspects of quality operations to ensure that laboratory testing operates in full compliance with sound scientific practice, GxP and Standard Operating Procedures (SOPs). 

 

Brief role description:

  • Batch record review: Review and approval of GxP documents, including Protocols, Technical Specification (TS), Batch Records, Workbooks, SOPs and all other QMS documentation.
  • Batch record review: Comply with all applicable policies, procedures and guidelines.
  • Batch record review: Conduct in-process or final audits and approval on manufacturing or testing documentation as they comply with the stated regulatory standards and the approved TS, protocol or SOPs.
  • Batch record review: Release of the certificate of analysis for GMP testing against the TS and associated documentation.
  • Batch record review: Prepare QA statement within each GLP final report specifying inspections date, and dates findings were reported to the Study Director and management.
  • Prepare and report QA metrics to measure operational compliance.
  • Review and approve deviations, anomalous results, OOS, positive results and CAPAs.
  • Assist in investigations from events, complaints or data audits.
  • Assist self-inspections to ensure continuous improvement.
  • Comply with Health and Safety Executive regulations and undergo relevant training modules when required and actively takes necessary action when encountering unsafe situations.
  • Perform their duties according to the principles of Good Laboratory (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).

 

Who you are:

  • Degree in Life Sciences/Biology/Biotechnology or higher related degree
  • Minimum of 4 – 5 years of experience, within a similar Quality Assurance role i.e. batch record review.
  • Shows a desire and motivation to work in Quality and regulated environment.
  • Awareness of Biologics regulatory environment and GMP manufacturing topics.
  • A proactive approach to all aspects of Quality.
  • Fluent in both written and spoken English. 
  • Good communicator, dealing directly and effectively with operational teams and site QA and lab colleagues routinely.
  • Strong analytical and problem solving abilities.
  • Organized and logical in defining workload and delivering projects.
Job Requisition ID:  201352
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.


Job Segment: Biotech, QA, Quality Assurance, Pharmaceutical, Quality, Science, Technology

Apply now »