Posted Wednesday 15 January 2025 at 06:00
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
We employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it.
People join Quotient Sciences because we are a respected member of the drug development community that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. Summary of job purpose Internal QC audit of bioanalysis in accordance with regulatory and company procedures To comply & adhere to GxP guidelines and regulations as required of this role. Main tasks and responsibilities QC audit of ICP-MS, GC-MS and LC-MS bioanalytical assay validation, analysis and data transfer in compliance with relevant regulatory requirements, internal policies/procedures and client requirements where appropriate. Prepare and audit study-specific documentation (i.e. protocol/SAO/reports) for study directors and clients in a timely manner. Assist study directors with delivery of their duties, including client contact. Prepare and update documentation (policies, procedures, guidance and methods) that are critical to operation of bioanalysis. Support & participate in client and regulatory audits. Support facility and process Quality Assurance Audits. Ensures work is conducted in compliance with relevant regulatory requirements, internal policies/procedures and client requirements where appropriate. Works with due regard to health & safety of self & others. Works flexibly across the site to meet business needs. Qualifications and experience required for competent performance BSc or equivalent in relevant scientific subject. Previous experience in the application of mass spectrometry-based bioanalytical methodologies in a pharmaceutical environment would be advantageous. Ability to demonstrate good interpersonal and communication skills, both written and oral, and must be self-motivated. A high level of personal integrity and commitment is essential, as is a flexible approach to new work challenges. Application Requirements
When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
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We employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it.
People join Quotient Sciences because we are a respected member of the drug development community that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. Summary of job purpose Internal QC audit of bioanalysis in accordance with regulatory and company procedures To comply & adhere to GxP guidelines and regulations as required of this role. Main tasks and responsibilities QC audit of ICP-MS, GC-MS and LC-MS bioanalytical assay validation, analysis and data transfer in compliance with relevant regulatory requirements, internal policies/procedures and client requirements where appropriate. Prepare and audit study-specific documentation (i.e. protocol/SAO/reports) for study directors and clients in a timely manner. Assist study directors with delivery of their duties, including client contact. Prepare and update documentation (policies, procedures, guidance and methods) that are critical to operation of bioanalysis. Support & participate in client and regulatory audits. Support facility and process Quality Assurance Audits. Ensures work is conducted in compliance with relevant regulatory requirements, internal policies/procedures and client requirements where appropriate. Works with due regard to health & safety of self & others. Works flexibly across the site to meet business needs. Qualifications and experience required for competent performance BSc or equivalent in relevant scientific subject. Previous experience in the application of mass spectrometry-based bioanalytical methodologies in a pharmaceutical environment would be advantageous. Ability to demonstrate good interpersonal and communication skills, both written and oral, and must be self-motivated. A high level of personal integrity and commitment is essential, as is a flexible approach to new work challenges. Application Requirements
When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
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