Quality Assurance Analytical Supervisor

4 weeks ago

Plymouth, Plymouth, United Kingdom Advanced Medical Solutions Full time
Position Overview

Quality Assurance Analytical Supervisor at Advanced Medical Solutions

About Advanced Medical Solutions:

Advanced Medical Solutions (AMS) is a premier independent innovator and manufacturer specializing in advanced tissue-healing technologies, dedicated to delivering superior quality outcomes for patients while providing value to healthcare payers. Our extensive portfolio includes a variety of surgical products such as tissue adhesives, sutures, haemostats, internal fixation devices, and internal sealants, marketed under renowned brands including LiquiBand, RESORBA, LiquiBandFix8, LIQUIFIXTM, and Seal-G. Additionally, AMS offers wound care dressings like silver alginates, alginates, and foams through our ActivHeal brand and other private labels. Since 2019, AMS has expanded through five strategic acquisitions, enhancing our capabilities in the field.

With manufacturing facilities located in multiple countries, AMS products are distributed globally through a network of regional and multinational partners, as well as our own direct sales teams. Our research and development innovation hubs are strategically positioned across various countries. Established in 1991, AMS employs over 800 dedicated professionals. We are committed to fostering an inclusive workplace, ensuring equal employment opportunities for all applicants, and promoting diversity within our workforce.

Role Purpose:

The Quality Assurance Analytical Supervisor is accountable for overseeing the Quality Control Analytical function. This role involves conducting analytical testing and completing quality system documentation to support operational requirements. The supervisor serves as the subject matter expert for the analytical team.

Key Responsibilities:

  • Manage the daily operations of the QC Analytical Team, providing guidance and ensuring that site requirements are fulfilled.
  • Represent QC analytical needs throughout all phases of product design and development to ensure manufacturability, reliability, and cost efficiency.
  • Adhere to quality control system protocols and ensure that documentation is accurately completed and maintained.
  • Ensure that all inspection and testing materials and equipment are properly cleaned, handled, and stored to maintain their accuracy and usability.
  • Conduct timely and effective testing of all routine products and samples in accordance with approved documentation and quality management system standards.
  • Perform testing for non-routine tasks, including validation samples as necessary.
  • Ensure that all chemicals and reagents are prepared accurately, remain within their expiration dates, and are traceable to test results.
  • Maintain adequate stock levels of materials, chemicals, reagents, and equipment required for QC testing.
  • Actively engage in investigating quality issues, such as customer complaints and non-conforming materials, and identify effective corrective and preventive actions (CAPA) as needed.
  • Progress and implement assigned actions to address non-conformities promptly.
  • Facilitate communication between departments (QA, R&D, and Production) regarding the status of QC testing and any identified issues.
  • Generate, update, and maintain QC laboratory procedures, testing methods, statistical sampling plans, and related documentation.
  • Support activities related to the Quality Management System, including managing non-conformances and CAPAs, and participating in compliance meetings.
  • Promote and uphold quality and cGLP standards across production and other departments.
  • Perform additional related duties as assigned.

Qualifications:

  • HNC or equivalent in a scientific discipline or relevant experience typically acquired through a minimum of 4 years in the medical device or pharmaceutical sectors.
  • Demonstrated leadership experience.
  • Strong understanding of GLP principles.
  • Familiarity with analytical techniques.
  • Proficient in spreadsheet and word processing applications.
  • Ability to independently plan, execute, and resolve moderate issues.
  • Excellent oral and written communication skills.
  • Computer literate, with knowledge of Word, PowerPoint, and Excel to effectively produce reports and analyze data.
  • Able to work autonomously and collaboratively within a multidisciplinary team.
  • Detail-oriented with a keen focus on accuracy.
  • Adaptable to changing work environments to meet production demands.
  • Proficient in Microsoft Office applications and ERP systems.

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