Quality Assurance Associate

Found in: Talent UK C2 - 2 weeks ago

Newbridge, United Kingdom Marken Full time

Description

Title:  

Quality Assurance Associate 

Job Purpose:  

The Quality Assurance Associate is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken’s Storage, Distribution and Transportation, Kit Production Facility. The QAA also need to ensure compliance with applicable regional and local regulations and requirements, and customer requirements as appropriate, but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485 and ISO 9001. 

Main Duties and Responsibilities  

Implement, communicate and maintain company’s quality systems at the facility, in compliance with Marken’s Global Quality Management System (QMS) requirements. Interact with clients on Quality Assurance (QA)/ GxP related matters. Effectively interact with Marken Departments and stakeholders to maintain that all QA tasks are appropriately supported by QA. Oversee an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated corrective and preventive actions (CAPA). Perform audits of external service providers as part of the vendor selection process. Tracking and overseeing all commitments for actions or changes made by Marken from previous audits. Host client audits and regulatory inspections, manage the audit report responses and act as Marken’s main representative, including and preparing of appropriate materials required within those audits when applicable. Manage issues and CAPA plans, collate CAPA metrics, and identify and implement quality improvement initiatives. Oversee activities that conclude on the appropriate close-out of all CAPA entries. Identify relevant GxP/ Quality related training needs and deliver or make they are deliver where required. Manage the change control. Ensuring that the Marken Quality System and GxP Program are implemented and maintained. Assisting in the evaluation of Marken-designated vendors and/or out-sourced activities. Ensuring the accuracy and quality of records and documents. Monitor that training for all personnel is conducted and documented. Coordinating and promptly performing any recall activity. Participate actively in all the internal Quality and/ or designated meetings. Keep informed of regulatory changes in Country/Region and prompt updates to SOPs as needed.

General  

Perform activities assigned by the QA Management. Travel as reasonably requested by the Line Manager to the performance of duties. Support your line manager, that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.

Requirements:  

Knowledge of Good Manufacturing Practice, Good Storage Practice and Good Distribution Practice guidelines. · Knowledge of local regulations. · Previous experience in Quality Management Systems with an eye for details. Excellent written and oral communication skills. · Good interpersonal skills · Organized, methodical and efficient approach to work. · Proficient use of Microsoft office · Fluent in English 2+ years of relevant experience working in a Quality Assurance role within a GSP/GMP/GDP regulated position. Associate degree and/or equivalent university degree/ certifications.

Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production. 

Moving Our World Forward by Delivering What Matters. 

#LI-AD1 IND123

  • Billing Associate

    4 days ago

    Newbridge, United Kingdom Marken Full time

    **Title**: Billing Associate **Job Purpose**: To assess - on a weekly and/or monthly basis (Client-dependent) - the ability to accurately bill Clients based on the accuracy of raw data available and then to perform a quality control check on billing accuracy, identifying gaps and recommending plans for their resolution. The person will be responsible for...

  • Pts Warehouse Assistant

    3 weeks ago

    Newbridge, United Kingdom PTS Full time

    **#BelongWithUs**: Come and join us as a Warehouse Assistant to help us grow, deliver sales and exceed customer expectations **The role**: As a Warehouse Assistant, you’ll be committed to delivering an outstanding level of service, and you’ll be professional, driven and enthusiastic. The Warehouse Assistant role reports into the branch management team...

  • Pts Warehouse Assistant

    2 weeks ago

    Newbridge, United Kingdom City Plumbing Full time

    **#BelongWithUs** Come and join us as a Warehouse Assistant to help us grow, deliver sales and exceed customer expectations **The role**: As a Warehouse Assistant, you’ll be committed to delivering an outstanding level of service, and you’ll be professional, driven and enthusiastic.The Warehouse Assistant role reports into the branch management team and...

  • Met Technician

    3 days ago

    Newbridge, United Kingdom Arnold Clark Full time

    We’re recruiting for a MET Technician to work at our Ratho Bodyshop in Edinburgh **Hours** Full time, Monday - Thursday, 8am - 5.30pm, Friday, 8am - 16.30pm **About the role** As an MET Technician for Arnold Clark, you’ll be responsible for ensuring work is carried out to the highest standards, and that quality check paperwork is completed for every...

  • Assistant Accountant

    Found in: beBee S GB - 3 weeks ago

    Newbridge, United Kingdom Element Materials Technology Full time

    Element has an opportunity for a new Assistant Accountant to join our growing Global Business Services team based in Edinburgh. Supporting across our expanding GL team, this is a fantastic opportunity to embark on and develop your Accountancy career within our marketing leading, global TIC business. This role would be perfect for an ambitious, highly...

  • Accounts Payable Representative

    Found in: beBee S GB - 2 weeks ago

    Newbridge, United Kingdom Element Materials Technology Full time

    Element has an opportunity for an Accounts Payable (AP) Representative. In this role you will be responsible for accounts payable duties, supporting multiple labs and / or locations. This position plays a crucial role in the daily upkeep of accounts payable, fielding phone calls from vendors and Element laboratories, ensuring invoices are entered into...

  • Accounts Payable Representative

    Found in: beBee jobs GB - 3 weeks ago

    Newbridge, Caerphilly County Borough, United Kingdom Element Materials Technology Full time

    Element has an opportunity for an Accounts Payable (AP) Representative. In this role you will be responsible for accounts payable duties, supporting multiple labs and / or locations. This position plays a crucial role in the daily upkeep of accounts payable, fielding phone calls from vendors and Element laboratories, ensuring invoices are entered into...

  • Technical Lead

    5 days ago

    Newbridge, United Kingdom Marken Full time

    **Title**: Technical Lead **Job Purpose**: Bringing experience, expertise, guidance and leadership to the overall technical direction of the development and continuous modernization of our core logistics operations management system, Marken Maestro. **Main Duties and Responsibilities**: - Be deeply committed to continuous improvement, refactoring, TDD and...

  • Financial Accounting Manager

    Found in: beBee S GB - 2 weeks ago

    Newbridge, United Kingdom Element Materials Technology Full time

    Element has an opportunity for a new Financial Accounting Manager to join our growing team. This is a great opportunity to develop your Finance career within a Global testing, inspection and certification TIC business.Responsible for preparation of monthly consolidated balance sheet and cash flowReviewing Cognos submissions from subsidiariesEnsuring controls...

  • Financial Accounting Manager

    Found in: beBee jobs GB - 2 weeks ago

    Newbridge, Caerphilly County Borough, United Kingdom Element Materials Technology Full time

    Element has an opportunity for a new Financial Accounting Manager to join our growing team. This is a great opportunity to develop your Finance career within a Global testing, inspection and certification TIC business.Responsible for preparation of monthly consolidated balance sheet and cash flowReviewing Cognos submissions from subsidiariesEnsuring controls...

  • Field Sales Advisor

    1 week ago

    Newbridge, Caerphilly, United Kingdom HSS Hire Ireland Full time

    As an Internal Sales Consultant You'll collaborate with customers from diverse sources, including existing, prospective, and lapsed clients. You'll adeptly tailor your account and sales strategies to meet their unique needs and foster lasting business relationships. Our benefits include additional Holiday buy scheme, exclusive company discounts on hire...

  • Sales Consultant

    1 week ago

    Newbridge, Caerphilly, United Kingdom HSS Hire Ireland Full time

    As an Internal Sales Consultant You'll collaborate with customers from diverse sources, including existing, prospective, and lapsed clients. You'll adeptly tailor your account and sales strategies to meet their unique needs and foster lasting business relationships. This role not only promises ample room for personal growth and development but also...

  • Environmental and Compliance Manager

    3 weeks ago

    Newbridge, Caerphilly, United Kingdom Bord Na Mona Full time

    BNM RECYCLING Open to Public Competition Our BNM Recycling Business Unit currently has a need for an Environmental Compliance Manager. The role will be based from Bord na Mona Recycling Newbridge and will report to the Head of Operations. proactively identify situations that may pose a compliance risk to the Resource Recovery business, and guide the...

  • Environmental Compliance Manager

    3 weeks ago

    Newbridge, Caerphilly, United Kingdom Bord Na Mona Full time

    BNM RECYCLING Open to Public Competition Our BNM Recycling Business Unit currently has a need for an Environmental Compliance Manager. The role will be based from Bord na Mona Recycling Newbridge and will report to the Head of Operations. The successful candidate will; proactively identify situations that may pose a compliance risk to the Resource...

  • Lead Electrical Engineer

    Found in: Whatjobs ES C2 - 1 week ago

    Newbridge, City of Edinburgh, United Kingdom Talent Solution Partners Full time

    Lead Electrical Engineer £46,000 Basic, 25 Days Holiday + Overtime + Progression A large, well established facilities organisation are currently recruiting a lead electrical engineer to work at a state of the art, aerospace manufacturing plant based in Edinburgh. Oversees and/or coordinates maintenance/repair work assignments performed by technicians,...