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Analytical Operations Associate

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Quotient Sciences

5d ago

  • Job
    Full-time
    Mid Level
  • Science
    Healthcare
  • Reading

AI generated summary

  • You need a minimum HND/HNC, 3 years in Analytical Chemistry, cGMP experience, knowledge of ALCOA+, analytical techniques, strong communication skills, attention to detail, and preferably Waters Empower knowledge.
  • You will verify lab data, ensure compliance with GMP, support analytical documentation, handle raw material testing, manage stability samples, and communicate effectively with analysts.

Requirements

  • 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.

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.

FAQs

What is the job title for this position?

The job title is Analytical Operations Associate.

Is this a full-time or part-time position?

This is a part-time position requiring 22.5 hours per week.

What are the main responsibilities of the Analytical Operations Associate?

The main responsibilities include reviewing laboratory data, ensuring compliance with GMP, authoring and reviewing analytical documentation, supporting raw material release activities, and assisting with stability pulls and external testing.

What qualifications are required for this role?

A minimum HND/HNC or equivalent experience in a laboratory-focused discipline, along with a minimum of 3 years of experience in Pharmaceutical or Analytical Chemistry, is required.

Is experience with Waters Empower systems preferred for this position?

Yes, some knowledge in the use of Waters Empower systems is preferred.

Are there any specific skills required for this role?

Yes, very good interpersonal and communication skills, attention to detail, and good documentation writing are required.

What does GMP stand for?

GMP stands for Good Manufacturing Practice.

Will I need to discuss data review issues with a supervisor?

Yes, you are expected to discuss any data review issues in a timely manner with your supervisor for guidance.

Can I apply for this role if I am under 18 years old?

No, you must be aged 18 years or over to apply for this position.

Does Quotient Sciences have a commitment to diversity and inclusion?

Yes, Quotient Sciences is committed to creating a diverse workforce and workplace culture that supports acceptance for every individual within the organization.

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Quotient Sciences

Molecule to cure. Fast.

Manufacturing & Electronics
Industry
1001-5000
Employees
1990
Founded Year

Mission & Purpose

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 save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, molecules need to become cures, fast. Because humanity needs solutions, fast. We employ over 1,300+ staff and operate from state-of-the-art manufacturing and clinical facilities in the US and UK. Our people make Quotient Sciences a special place to work. We are a dedicated team passionate about innovating and transforming drug development to help our customers develop new medicines for patients in need. We recruit people that are committed to making a difference, who excel at customer service and are always willing to go the extra mile. Teamwork is integral to our culture and success — helping, supporting and mentoring run through our DNA. Expect to join an empowering and innovative culture, where we encourage continuous improvement and offer opportunities to learn and develop every day.