QA Associate - Witney, United Kingdom - Abbott Laboratories

Abbott Laboratories Witney, United Kingdom

6 days ago

OTHER

Description

Abbott is about the power of health. For more than 130 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.Abbott Diabetes Care designs, develops and manufactures leading-edge blood glucose monitoring technology for use in both home and hospital settings, including our revolutionary Freestyle Libre Flash Glucose Monitoring System.In our Centre of Excellence in Witney, we design, develop and manufacture test strips and biosensors which are used by patients and healthcare professionals for the day-to-day management of diabetes.As a result of strong business growth, industry-leading product development in the biosensor business and a long-term commitment to manufacturing and innovation in our Witney Centre of Excellence, we have a fantastic opportunity for a Quality Assurance Associate Manager to join our expanding highly skilled team.The key roles and responsibilities are as follows:Main purpose of role

Support functional area ensuring compliance to site and divisional policies and procedures.
Support audits and inspections
Support the development, implementation and improvement of ADC quality systems for Document Control, Final Release, Calibration and Training and Product Test to ensure effective and compliant processes and procedures which meet the needs of ADC and its customers.
Manage own and support the teams Health and Safety within the working environment; highlight opportunities for improvement to EHS performance.
Ensure that all communication, interpersonal interactions and business behaviours are consistent with the Abbott Code of Conduct

Main responsibilities

Document Control - Document Changes: Support the creation and progression of document changes through Agile (including Originating, Reviewing, Mastering and Releasing) Parts Changes: Support the creation and progression of Parts in MACPAC and Agile (including BOMs, IVRS, Routings, Artwork, & ROM Editor)
Document Control Training: Providing training for members of Document Control in Agile and MACPAC.
Records: Ensure records, including procedures / work instructions / forms / templates are maintained, accurate & periodically reviewed.
Responsible for the submission and retrieval of items from offsite storage
Approval and Release: Support the activities to review batch records, compile the Device History Record and approval of in-process product and finished goods for all product lines.
Approval of purchased components – Support the Inspect and release of label copy, including the mastering on new label copy.
MACPAC Transactions – Support the completion of the required actions to disposition product - Release, Hold, Reject.
Calibration
Perform Calibrations: Perform internal and external calibrations as required ensuring calibrations are performed to the required standard and accuracy.
Calibration records: Ensure calibration records, including calibration alerts / requests / procedures and training materials, are maintained, accurate & periodically reviewed.
Maximo - Asset creation, data sheets, Preventive Maintenance schedules and provide training.
Training
ISOtrain Curricula – Create and control curriculums. Building curriculums in ISOtrain Maintain and complete periodic reviews of curriculums.
Site Mandatory Training – Plan training for Site. Schedule instructor led training events (EHS, GXP). Facilitate event e.g., trainer and room are available.
Training Administration – Manage the training system. Uploading Training documentation. Late training remediation.
Training System – Create and Manage User Accounts, Modules and Courses. User Account - Set Up, Modify, Terminate, Reset. Modules and Courses – Building and Revising. Report Running.
Product Test Reviewer
Be responsible for and support the scheduling, analysis, approval of results, accurate recording and review of data of finished products, development/validation trials, product performance monitoring items and associated activities within the scope of Product Test, making sure activities are completed as scheduled on time and in full to meet the needs of the business and customers.
Pro-actively support new/changed products and processes within the area including associated validation/verification activities.
Product Test Training: Be responsible for and support the design, planning and delivery of new training materials and the review, evaluation and delivery of existing training materials within the area.
Product Test Technician
Be responsible for and support the set-up, sampling, testing and accurate recording and review of data of finished products, development/validation trials, product performance monitoring items and associated activities within the scope of Product Test, making sure activities are completed as scheduled on time and in full to meet the needs of the business and customers.
Pro-actively support new/changed products and processes within the area, including associated validation/verification activities.
Product Test Training: Be responsible for and support the design, planning and delivery of new training materials and the review, evaluation, and delivery of existing training materials within the area.
Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management.

In addition to a competitive salary, Abbott offers a highly attractive benefits package which includes a defined-contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme which you can tailor to your own requirements. Here at Witney, we also support our employees to live life to the fullest – whether it's joining our couch to 5k team, tending the allotments, learning to be a bee keeper, dropping in for a yoga session, or getting on board with a selection of other activities, there is plenty going for you to engage with as and when you wish

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QA Associate - Witney, United Kingdom - Abbott Laboratories

Description

Support functional area ensuring compliance to site and divisional policies and procedures.

Support audits and inspections

Support the development, implementation and improvement of ADC quality systems for Document Control, Final Release, Calibration and Training and Product Test to ensure effective and compliant processes and procedures which meet the needs of ADC and its customers.

Manage own and support the teams Health and Safety within the working environment; highlight opportunities for improvement to EHS performance.

Ensure that all communication, interpersonal interactions and business behaviours are consistent with the Abbott Code of Conduct

Main responsibilities

Document Control Training: Providing training for members of Document Control in Agile and MACPAC.

Records: Ensure records, including procedures / work instructions / forms / templates are maintained, accurate & periodically reviewed.

Responsible for the submission and retrieval of items from offsite storage

Approval and Release: Support the activities to review batch records, compile the Device History Record and approval of in-process product and finished goods for all product lines.

Approval of purchased components – Support the Inspect and release of label copy, including the mastering on new label copy.

MACPAC Transactions – Support the completion of the required actions to disposition product - Release, Hold, Reject.

Calibration

Perform Calibrations: Perform internal and external calibrations as required ensuring calibrations are performed to the required standard and accuracy.

Calibration records: Ensure calibration records, including calibration alerts / requests / procedures and training materials, are maintained, accurate & periodically reviewed.

Maximo - Asset creation, data sheets, Preventive Maintenance schedules and provide training.

Training

ISOtrain Curricula – Create and control curriculums. Building curriculums in ISOtrain Maintain and complete periodic reviews of curriculums.

Site Mandatory Training – Plan training for Site. Schedule instructor led training events (EHS, GXP). Facilitate event e.g., trainer and room are available.

Training Administration – Manage the training system. Uploading Training documentation. Late training remediation.

Training System – Create and Manage User Accounts, Modules and Courses. User Account - Set Up, Modify, Terminate, Reset. Modules and Courses – Building and Revising. Report Running.

Product Test Reviewer

Pro-actively support new/changed products and processes within the area including associated validation/verification activities.

Product Test Training: Be responsible for and support the design, planning and delivery of new training materials and the review, evaluation and delivery of existing training materials within the area.

Product Test Technician

Pro-actively support new/changed products and processes within the area, including associated validation/verification activities.

Product Test Training: Be responsible for and support the design, planning and delivery of new training materials and the review, evaluation, and delivery of existing training materials within the area.

Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management.