Quality Systems Analyst

Posted 17 Days Ago
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Plymouth, Devon, England, GBR
In-Office
Junior
Healthtech • Manufacturing
The Role
Perform routine analytical testing (GC-FID, HPLC, Karl Fischer, viscometry, tensile), support in-process and final product release, maintain accurate inspection records and Device History Files, ensure GMP compliance, write protocols/reports, mentor lab practices, support QA, and lead improvement projects.
Summary Generated by Built In
Company Description

Who are Advanced Medical Solutions?
 
AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand®, RESORBA®, LiquiBandFix8®, LIQUIFIX™, Peters Surgical, Ifabond, Vitalitec and Seal-G®. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal® brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, an Israeli developer of innovative internal sealants, Biomatlante, a French developer and manufacturer of surgical biomaterials, Raleigh, a leading UK coater and converter of woundcare and bio-diagnostics materials, AFS Medical, an Austrian specialist surgical business, Connexicon, an Irish tissue adhesives specialist, Syntacoll a German specialist in collagen-based absorbable surgical implants and Peters Surgical a global provider of specialty surgical sutures, mechanical haemostasis and internal cyanoacrylate devices. AMS's products, manufactured in the UK, Germany, France, the Netherlands, Thailand, India, the Czech Republic and Israel, are sold globally via a network of multinational or regional partners and distributors, as well as via AMS's own direct sales forces in the UK, Germany, Austria, France, Poland, Benelux, India, the Czech Republic and Russia. The Group has R&D innovation hubs in the UK, Ireland, Germany, France and Israel. Established in 1991, the Group has more than 1,500 employees. For more information, please see www.admedsol.com

 

Job Description

What will this role involve?

  • Perform routine analytical analysis on physical test methods, GC-FID, HPLC and Karl Fischer.
  • Mentor / provide guidance on Lab procedures / practices.
  • Provide analytical support to other departments within AMS.
  • Protocol & Report writing.
  • Perform viscometry, set time and tensile testing.
  • Responsible for in-process inspection and testing, and testing for final product release.
  • Responsible for recording and maintaining accurate records of inspections conducted.
  • Ensuring that Good Manufacturing Practice (GMP) is maintained at all times.
  • Supporting QA with day to day tasks.
  • Project Management.
  • Improvement Projects.
  • Any other reasonable requirement as required to meet the business objectives.
  • Chemical & performance analysis of raw materials as part of goods received inspection.
  • Chemical & performance analysis of manufactured products as part of QA product release.
  • Responsible for ensuring that the Device History Files are maintained.

What we're looking for?

  • BSc Chemistry or equivalent with 2-3 years related experience within laboratory environment.
  • Ability to write reports & effectively present information and respond to questions from AMS personnel.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Computer literacy.
  • This position requires attention to detail, and the ability to follow defined procedures.
  • The role also requires interaction with other departments.
  • A background in an analytical / test laboratory environment, within a controlled QMS system.
  • A very thorough person, with significant attention to detail.
  • Able to work independently, but also as part of a small team.
  • Able to communicate effectively at all levels within the organisation.

 

Qualifications

BSc Chemistry or equivalent with 2-3 years related experience within laboratory environment.

Skills Required

  • BSc in Chemistry or equivalent with 2-3 years laboratory experience
  • Hands-on experience with GC-FID, HPLC and Karl Fischer titration
  • Experience with viscometry and tensile testing
  • Working knowledge of GMP and maintaining Device History Files (DHF)
  • Experience working within a controlled Quality Management System (QMS)
  • Ability to write protocols and analytical reports
  • Strong attention to detail and ability to follow defined procedures
  • Computer literacy
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Ability to communicate effectively and work independently and within a small team
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The Company
1,500 Employees
Year Founded: 1993

What We Do

Advanced Medical Solutions Group plc is a UK-based developer and manufacturer of world-leading advanced wound care and wound closure products. Specializing in tissue-healing technologies, the company develops, manufactures, and distributes a wide range of surgical and woundcare products across the United Kingdom, Germany, Europe, the United States, and other international markets.

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