At a Glance
- Tasks: Review lab data and documentation, ensuring compliance with GMP standards.
- Company: Quotient Sciences accelerates drug development, helping biotech and pharma deliver solutions faster.
- Benefits: Part-time hours, flexible work environment, and a chance to contribute to meaningful healthcare solutions.
- Why this job: Join a respected team focused on innovation and making a real impact in the pharmaceutical industry.
- Qualifications: Minimum HND/HNC or equivalent; 3 years in Pharmaceutical or Analytical Chemistry required.
- Other info: Diversity and inclusion are core values; applicants must be 18+.
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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.
The Role
We are looking for an Analytical Operations Associate for our site in Reading. This is a part-time opportunity, 22.5 hours per week. In this role you will be required to perform the review of analysis, documentation and raw data generated (including Empower and ELN) and recorded in compliance with GMP as per associated documentation.
The purpose of the role will also be to author and review of analytical documentation. You will be involved in raw material release activities, external testing support and stability pulls and set down and archiving of analytical documentations as required.
Main tasks and responsibilities
- Support activities for data verification, review of laboratory data including lab notebooks, ELN, raw data packages (including Waters Empower) and Excel spread sheets etc.
- Ensuring all work being reviewed has been generated and recorded in compliance with GMP and as per SOP, test method, protocols or any relevant documentation.
- Awareness of ALCOA+ and perform all required activities to support data integrity goals as required with minimal right first time issues.
- Understands how own work fits into the overall department goals, KPIs and can assess the impact of changes and work to meet set targets and timelines.
- Good communication (written and oral) with analysts to ensure analyses are signed off in a timely manner to meet the cycle time and deliverable targets.
- Discusses data review issues in a timely with the supervisor for guidance.
- Support the generation of analytical documentation for QC, Development and Raw Materials release activities (protocols, reports, COAs, specifications, ISR etc).
- Support raw materials release testing where required under minimal supervision.
- Support external testing requirements, including but not limited to requesting quotations and shipment of samples.
- Support stability pulls, setdown and stability sample disposal activities once adequately trained.
Qualifications and experience required for competent performance
- Minimum HND/HNC or equivalent experience in a laboratory focussed discipline.
- Minimum 3 years in Pharmaceutical, Analytical Chemistry.
- Experience of working to cGMP, reviewing of GMP documentations and understanding of the ALCOA+ principle
- General awareness and understanding of routine analytical techniques and data used within pharmaceutical industries.
- Very good interpersonal and communication skills.
- Very good attention to detail and good documentation writing
- Preferably some knowledge in the use of Waters Empower systems.
Please note, this is a part time opportunity 3 days per week, 22.5 hours.
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.
Seniority level
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Seniority level
Associate
Employment type
-
Employment type
Part-time
Job function
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Job function
Manufacturing
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Industries
Pharmaceutical Manufacturing
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Analytical Operations Associate (Part-time Opportunity) employer: Quotient Sciences
Contact Detail:
Quotient Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Analytical Operations Associate (Part-time Opportunity)
✨Tip Number 1
Familiarise yourself with the principles of ALCOA+ and cGMP regulations. Understanding these concepts will not only help you in the role but also demonstrate your commitment to quality and compliance during any discussions with the hiring team.
✨Tip Number 2
Brush up on your knowledge of Waters Empower systems, as this is specifically mentioned in the job description. If you have experience with similar software, be ready to discuss how those skills can transfer to using Empower effectively.
✨Tip Number 3
Prepare to showcase your attention to detail and documentation skills. Think of examples from your previous roles where you ensured data integrity or improved documentation processes, as these are crucial for the Analytical Operations Associate position.
✨Tip Number 4
Network with current or former employees of Quotient Sciences if possible. Engaging with them can provide insights into the company culture and expectations, which can be invaluable during interviews.
We think you need these skills to ace Analytical Operations Associate (Part-time Opportunity)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in analytical chemistry and compliance with GMP. Emphasise any specific roles where you have reviewed laboratory data or authored analytical documentation.
Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the role at Quotient Sciences. Mention your understanding of ALCOA+ principles and how your skills align with their commitment to innovation and quality in drug development.
Highlight Relevant Experience: Clearly outline your experience in pharmaceutical environments, particularly any work related to data verification and documentation review. Use specific examples to demonstrate your attention to detail and communication skills.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no spelling or grammatical errors, as these can detract from your professionalism and attention to detail, which are crucial for this role.
How to prepare for a job interview at Quotient Sciences
✨Understand GMP and ALCOA+ Principles
Make sure you have a solid grasp of Good Manufacturing Practices (GMP) and the ALCOA+ principles. Be prepared to discuss how these concepts apply to your previous work experience, especially in relation to data integrity and documentation.
✨Showcase Your Analytical Skills
Highlight your experience with analytical techniques and tools, particularly Waters Empower systems if applicable. Be ready to provide examples of how you've successfully reviewed laboratory data and ensured compliance with relevant documentation.
✨Communicate Effectively
Demonstrate your strong communication skills during the interview. Practice articulating your thoughts clearly and concisely, especially when discussing complex topics like data review issues or analytical documentation.
✨Align with Company Values
Familiarise yourself with Quotient Sciences' commitment to innovation and diversity. Be prepared to discuss how your personal values align with their mission and how you can contribute to their culture of acceptance and collaboration.