Senior QA Associate Operations Lead

3 weeks ago


St Albans, Hertfordshire, United Kingdom Baxter Full time

Transforming Healthcare through Quality Excellence

Baxter, a global leader in pharmaceuticals, seeks a Senior QA Associate Operations Lead to join our Elstree, UK team. As a key member of our manufacturing operations, you will play a crucial role in ensuring the quality and compliance of our life-saving products.

Main Responsibilities:

  • Support the batch review process to ensure flawless quality
  • Release raw materials and components for processing, and finished products to market
  • Investigate non-conformances, CAPAs, and complaints to maintain compliance with ISO13485 and FDA regulations
  • Compile release data for finished products, including product bioburden, sterilization, and test results
  • Collate, review, and complete batch documentation to support release
  • Ensure closure of deviations prior to release to ensure timely release of product
  • Document control: support document control activities, responsibility for filing/archiving completed DHRs and batch/order documentation
  • Deviation management: support quality investigations to support release of finished product
  • Liaise with Baxter staff and sub-contractors as appropriate to carry out investigations
  • Quality Assurance/Control: adhere to Baxter policies and procedures at all times and notify any deviations/exceptions from process
  • Support all aspects of the QMS through participation in internal audit and supplier audits
  • Support investigations into incidents such as complaints, and any subsequent field correct actions/recalls
  • Support regulatory inspections as required
  • Support change control projects, new product development projects, sterilization validations, endotoxin testing, environmental monitoring, and purified water testing
  • Manage the statistical process control (SPC) process for review of manufacturing and quality data
  • Administrative tasks for supplier quality QMS, creation of part numbers, and update of Bill of Materials
  • Participate in cross-functional project teams and attend meetings as a representative of Quality

Requirements:

  • Degree or equivalent qualification in a scientific, technical, or engineering subject desired but not essential if you can demonstrate 2+ years experience in a GMP environment
  • Experience working to ISO13485, FDA (21 CFR) part 820 or GMP (Orange Guide) compliant systems
  • Experience in reviewing and releasing finished product to market or for final disposition
  • Quality investigational tool training
  • Familiarity with NCR/CAPA, document control processes within a regulated QMS, and auditing
  • QA experience in cleanroom environments – sterile/aseptic manufacturing
  • Field of expertise: QA, cGMP, and Quality Systems in an Operational Quality environment
  • Knowledge of clean room control requirements
  • Excellent communication skills

About Baxter:

Baxter is a global pharmaceutical company dedicated to saving and sustaining lives. Our products and therapies are found in almost every hospital worldwide, in clinics, and in the home. We have pioneered significant medical innovations that transform healthcare.

Join us at Baxter:

As a Senior QA Associate Operations Lead, you will be part of a close-knit team of 36 employees in Elstree, UK. You will have the opportunity to work on a wide range of projects, from batch review to regulatory compliance, and contribute to the success of our manufacturing operations.

What we offer:

Baxter offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a workplace where you can do your best work and make a positive impact on people's lives.



  • St Albans, Hertfordshire, United Kingdom Baxter Full time

    Transforming Healthcare with BaxterBaxter is a global pharmaceutical company dedicated to saving and sustaining lives. We are seeking a highly skilled Senior QA Associate Operations Lead to join our team in Elstree, UK.As a Senior QA Associate Operations Lead, you will play a crucial role in our world-class manufacturing operations. Your attention to detail...


  • St Albans, Hertfordshire, United Kingdom Baxter Full time

    Transforming Healthcare through Quality ExcellenceBaxter, a global leader in pharmaceuticals, seeks a highly skilled Senior QA Associate Operations Lead to join our Elstree, UK team. As a key member of our world-class manufacturing operations, you will play a crucial role in ensuring the highest quality standards are met.Main Responsibilities:Support the...


  • St Albans, Hertfordshire, United Kingdom Shackleton Recruitment Group Ltd Full time

    About UsShackleton Recruitment Group Ltd is a highly technical and customer-facing organization.Job SummaryWe are seeking an experienced Senior Technical Operations Lead to join our team. The ideal candidate will have extensive knowledge of installation & small works as an engineer and/or supervisor, with experience in leading, inspiring, engaging and...


  • St Albans, Hertfordshire, United Kingdom Circana Full time

    Retail Operations AssociateAt Circana, we are seeking a Retail Operations Associate to join our field team. This role provides an essential function within our organization by supporting the collection of promotional activity across the UK.Key Responsibilities:Collect data from designated stores using a hand-held scanning device.Conduct availability checks...


  • St Albans, Hertfordshire, United Kingdom Circana Full time

    Retail Operations AssociateWe are seeking a skilled Retail Operations Associate to join our field team in various locations across the UK.The successful candidate will be responsible for collecting data from designated stores using a hand-held scanning device, as well as conducting availability checks in supermarkets.This is a flexible role with varying...


  • St Albans, Hertfordshire, United Kingdom beBee Professionals Full time £25,000 - £35,000

    beBee Professionals in St Albans is looking for an Operational Team Associate to join our fast-paced environment. As a key member of our team, you will be responsible for delivering excellent customer service and contributing to our operational success.Responsibilities:Engage with customers, providing service and support.Participate in all aspects of the...


  • St Albans, Hertfordshire, United Kingdom beBee Professionals Full time £25,000 - £35,000

    beBee Professionals in St Albans is looking for an Operational Team Associate to contribute to our fast-paced environment.Key Responsibilities:Provide service and support to customers, ensuring their needs are met.Participate in all aspects of the operational workflow, including customer engagement and team collaboration.Work closely with team members to...


  • St Albans, Hertfordshire, United Kingdom https:jobs-redefined.cositemap Full time

    At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the world's most complex challenges and build legacies for future...


  • St Albans, Hertfordshire, United Kingdom Lotus Bakeries Full time

    We are seeking a highly skilled and experienced Senior Technical Specialist to join our team at Lotus Bakeries. The successful candidate will be responsible for ensuring the quality and safety of our products, working closely with cross-functional teams and suppliers to drive forward continuous improvement plans.Key responsibilities include:Visiting and...


  • St Albans, Hertfordshire, United Kingdom Michael Page Full time

    Michael Page is seeking a commercially astute Strategic Financial Operations Lead to join their dynamic team in St. Albans.Company OverviewThe successful candidate will take ownership of the financial operations, partnering with key stakeholders to drive business performance and strategic decision-making.Job DescriptionLead the Monthly Management Accounts...

  • Operations Lead

    4 weeks ago


    St Albans, Hertfordshire, United Kingdom beBee Professionals Full time £45,000 - £65,000

    We are looking for an experienced Operations Lead to join our team at beBee Professionals in St Albans, UK. The successful candidate will be responsible for managing daily operations, driving team performance, and ensuring targets are met.Key Responsibilities:Manage and motivate the team to achieve performance targets and goals.Monitor and report on team...


  • St Albans, Hertfordshire, United Kingdom Franke Full time

    About FrankeWe, the Franke company, are a world-leading supplier of products and services for domestic kitchens, professional foodservice systems, and the convenience store sector. Our Coffee Systems division provides innovative solutions for professional coffee making.Our dynamic Finance team is seeking a skilled Deputy Finance Manager to support our Head...


  • St Albans, Hertfordshire, United Kingdom Michael Page Full time

    Michael Page is seeking a Senior Financial Operations Manager to join their dynamic team in a well-established FMCG manufacturer with an impressive growth trajectory. The successful candidate will take ownership of the financial operations while partnering with key stakeholders to drive business performance and strategic decision-making.Key...


  • St Albans, Hertfordshire, United Kingdom Blakemore Recruitment Full time

    We are currently seeking a highly skilled and experienced Senior Financial Planning Associate to join our Blakemore Recruitment team in St Albans, Herts. The ideal candidate will have a strong background in financial planning and be able to support the Financial Planners within our business to effectively and efficiently carry out all designated...


  • St Albans, Hertfordshire, United Kingdom Michael Page Finance Full time

    Michael Page Finance is seeking a commercially astute Senior Financial Operations Manager to join their dynamic team in St. Albans. The successful candidate will take ownership of the financial operations while partnering with key stakeholders to drive business performance and strategic decision-making.Key Responsibilities:Lead the monthly management...


  • St Albans, Hertfordshire, United Kingdom Michael Page Finance Full time

    Michael Page Finance is seeking a Senior Financial Operations Manager to join their dynamic team in St. Albans. The successful candidate will take ownership of the financial operations while partnering with key stakeholders to drive business performance and strategic decision-making.Key Responsibilities:Lead the monthly management accounts process, ensuring...


  • St Albans, Hertfordshire, United Kingdom Public Practice Recruitment Ltd Full time

    Job Title: Senior Accountant LeadWe are seeking an exceptional accountant and client relationship manager to join our team in St Albans, Hertfordshire. As a Senior Accountant Lead, you will be responsible for leading and managing staff, as well as career and personal development, and overseeing the allocation and flow of work within the department.Key...


  • St Albans, Hertfordshire, United Kingdom Public Practice Recruitment Ltd Full time

    Audit Senior Role in St AlbansThis is a fantastic opportunity to join a leading accountancy practice in St Albans, offering a clear path to progression and impressive benefits.As an Audit Senior, you will be responsible for supporting the delivery of audit assignments from planning to completion, working closely with senior team members.You will review...

  • Senior Producer

    2 months ago


    St Albans, Hertfordshire, United Kingdom Amiqus - Games Recruitment Specialists Full time

    Job Title: Senior ProducerAmiqus - Games Recruitment Specialists is seeking a highly skilled Senior Producer to join their team. As a Senior Producer, you will be responsible for collaborating with development partners to enhance the quality of video games while adhering to timelines and budgets.Key Responsibilities:Provide feedback to development teams...


  • St Albans, Hertfordshire, United Kingdom Bill's Management Full time

    Becoming a Senior Culinary Team Lead at Bill's Management means taking responsibility for a diverse, inclusive, and supportive team. You'll oversee the entire kitchen operation, ensuring high standards are maintained throughout the day.Key to your success will be the ability to motivate and lead your team members, empowering them to deliver exceptional...