Quality Assurance Specialist

Overview Quality Assurance Specialist is to promote and integrate quality into every aspect of our BioReliance biologics safety testing business in Singapore. The role performs batch record review (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). The post holder will contribute to the results of the QA team and is accountable for the quality of own work, solving problems of low complexity independently by identifying and selecting solutions and by analyzing information. The role can be performed independently with minimal guidance. What you do, what you will be responsible for, and the qualifications you bring will help ensure we continue to operate to the highest standards of safety and quality for our customers and patients. Responsibilities 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. Review and approve deviations, anomalous results, OOS, positive results and CAPAs. Assist in investigations from events, complaints or data audits. Conduct trend analysis for deviations and review / approve applicable CAPA records. Assist self-inspections to ensure continuous improvement. Perform and support client audits, regulatory inspections. Perform and support internal audits. Perform and support supplier audits. Comply with Health and Safety Executive regulations and undergo relevant training modules when required and actively take necessary action when encountering unsafe situations. Perform duties according to the principles of Good Laboratory (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). Qualifications Graduate degree in life sciences or higher related degree Minimum of 2 – 4 years of experience in a similar Quality Assurance role i.e. batch record review A desire and motivation to work in Quality and a 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, able to interact directly and effectively with operational teams and site QA and lab colleagues Strong analytical and problem solving abilities Organized and logical in defining workload and delivering projects Core Competencies Technical and problem solving skills Functional and technical knowledge to perform the job Ability to learn new skills quickly Use of logic to solve problems with effective solutions Decision-making Energy and drive; self-motivated; action-oriented Perseverance in pursuing goals and collaborating with others Professional and interpersonal skills; ability to relate well to people at all levels Team player who fosters collaboration Additional Local Needs Global mindset and willingness to engage in conference calls at out-of-office hours What we offer We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progressApply now and become a part of a team dedicated to Sparking Discovery and Elevating Humanity. #J-18808-Ljbffr