Smithers - Medical Device Testing Logo

Smithers - Medical Device Testing

Quality Assurance Officer

Reposted 4 Days Ago
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In-Office
Harrogate, North Yorkshire, England
Entry level
In-Office
Harrogate, North Yorkshire, England
Entry level
Conduct audits of scientific research protocols, data, reports, processes, facilities, and computer systems for compliance with GLP, MHRA, OECD, SOPs, and regulatory requirements. Report findings, maintain audit schedules and quality records, support sponsor and regulatory inspections, train operations staff, and identify and implement quality improvements.
The summary above was generated by AI

An exciting opportunity has arisen for a Quality Assurance (QA) Officer within the QA Department of Smithers Environmental Risk Sciences (ERS) Ltd, based in Harrogate.

The Business performs Environmental and Consumer Safety Contract Research and Regulatory Services for the Crop Protection, Pharmaceutical, Industrial Chemical, and the Consumer Product industries. Smithers ERS has performed standard guideline and higher-tiered Environmental studies for over 45 years and conducts studies to satisfy all Regulatory requirements globally.

Key offerings include Environmental Fate, Plant and Animal Metabolism, Aquatic and Terrestrial Ecotoxicology, Honeybee and Pollinator testing, Avian Toxicology, Residue, Analytical, and Product Chemistry, and Regulatory Risk assessment.


The Business is privately owned, highly entrepreneurial, relationship-driven and would provide a solid platform to further develop your skills and knowledge.
Reporting directly to the Director of Quality Assurance, you will work within our busy Quality Assurance (QA) Team to assure Management that the Company’s scientific research activities comply with Good Laboratory Practice (GLP) regulations (MHRA/OECD).


The Position


The role is full time at 37 hours per week, fully onsite. 


Essential Functions:


  • Conduct audits of protocols, data, reports, and processes to verify compliance with GLP, internal SOPs, and applicable regulatory guidelines (e.g. MHRA, OECD).
  • Accurately and concisely report audit findings to laboratory personnel and management.
  • Participate in facility, process, and computer system audits to ensure ongoing compliance and identify areas for improvement.
  • Maintain QA audit schedules, training records, and controlled documents.
  • Communicate effectively (verbal and written) when interacting with staff members.
  • Assist in preparing for and supporting sponsor, and regulatory inspections.
  • Provide training to operations staff in the areas of quality systems procedures (SOPs) and regulatory compliance.
  • Additional duties as assigned.


The successful candidate will possess the following skills and experience:


  • Bachelor of Science/Arts (BSc/BA) degree; degree in a science field is preferred.
  • Strong Quality Assurance experience, preferably in GLP or a proven work history in a regulatory environment working to GLP.
  • Comprehensive knowledge of, and the ability to interpret, MHRA/OECD GLP Regulations
  • Good writing, numeracy and computer skills.
  • Excellent communication skills, with the ability to work well with people at all levels of the Organisation.
  • Possess excellent organisational skills.
  • The ability to identify opportunities for improvement and drive to successful implementation.
  • Experience of CSV auditing and the ability to train others, in a range of QA related activities, would also be advantageous.

 

We Offer


We offer opportunities to work in a fast-paced team alongside bright, interesting colleagues while building a flexible and rewarding career.

As a Global employer, we also offer a generous benefits package to all our employees including private healthcare, employer matched pension contributions, free mortgage advice service, 25 days annual leave plus Bank Holidays, eyecare vouchers, Ride2Work scheme and more.


There is no better time to join us!


#LI-CJ1 #Smithers #QualityAssurance #QualityOfficer #EnvironmentalScienceJobs

Smithers - Medical Device Testing Mole Valley, England Office

Mole Valley, United Kingdom

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