Quality Assurance Scientist

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom 4basebio Full time
Position Overview

4basebio is a pioneering company in the field of gene synthesis, dedicated to delivering high-quality synthetic DNA for applications in gene therapy, vaccine development, and gene editing technologies, including RNA therapeutics. We are expanding our research and development teams to enhance our proprietary DNA manufacturing capabilities, including mRNA synthesis and the creation of nanoparticle vectors for nucleic acid delivery. We seek motivated and skilled professionals to join us in achieving our strategic objectives.

We are in search of a Quality Assurance Scientist whose main responsibilities will include testing, assessing, and reporting on in-process checks, batch release, incoming materials, raw materials, stability samples, validation processes, and other related tasks. This role also involves supporting the upkeep, organization, and monitoring of the quality control laboratories as necessary.

Key Responsibilities:

  • Conduct all Quality Assurance (QA) operations, which encompass analytical method testing, data evaluation, external QA management, sample oversight, standard operating procedure (SOP) drafting, validation processes, and preparation and cleaning of equipment and areas.
  • Analyze, evaluate, and trend data generated, ensuring that test records comply with Good Documentation Practices and maintain Data Integrity.
  • Participate in and lead investigations as needed, including Out of Specification (OOS) events, deviations, and quality incidents.
  • Take the lead in analytical method validations as the primary analyst/author when required.
  • Adhere to Good Manufacturing Practice (GMP) principles to guarantee that analytical testing and documentation are completed accurately, and that equipment is properly maintained.
  • Ensure compliance with Quality policies, SOPs, testing methods, and Health and Safety regulations.
  • Engage in cross-departmental meetings, troubleshooting, and improvement initiatives, collaborating to ensure alignment across Production, R&D, and Quality teams.
  • Support continuous improvement efforts and method optimization, taking the lead when necessary.
  • Assist in the transfer of new analytical methods from MSAT/R&D, leading execution as required.
  • Help monitor and maintain the facility and direct utilities in accordance with company and regulatory standards.
  • Undertake any other relevant roles and responsibilities that align with the skills and experience of the role holder, as requested.
  • Provide support and training to ensure that all QA work meets established quality standards.
  • Act as a deputy to senior QA personnel and fulfill supervisory responsibilities as needed.

Candidate Profile:

  • Bachelor of Science degree or equivalent professional experience.
  • Experience in a cGMP, cGLP, or regulated environment is preferred.
  • Demonstrable experience in a QA laboratory or similar role, with a solid understanding of analytical testing and equipment operation and troubleshooting.
  • Practical knowledge of relevant testing methods and processes, including DNA quantification, impurity profiling, and sampling is advantageous.
  • Detail-oriented with strong organizational and communication skills, experienced in adhering to SOPs and applying Good Documentation Practices.
  • Able to work independently or collaboratively within a team environment.
  • Enthusiastic and driven individual with a positive attitude.
  • Must possess the right to work in the UK.

What We Offer:

Competitive salary along with a comprehensive benefits package.

We appreciate your interest in joining the 4basebio team. Please note that we are unable to provide sponsorship for applicants whose current visa expires before June 2025.

No Agencies Please

Due to the high volume of applications, if you do not receive a response within six weeks, we thank you for your interest but kindly ask you to assume that you have not been selected for an interview on this occasion.

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