Quality Assurance Officer

Posted 26 Days Ago
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Harrogate, North Yorkshire, England, GBR
In-Office
Entry level
Pharmaceutical
The Role
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.
Summary Generated by Built In

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

Skills Required

  • Bachelor of Science or Arts degree
  • Strong Quality Assurance experience, preferably in GLP or a regulatory environment
  • Knowledge of and ability to interpret MHRA and OECD GLP regulations
  • Good writing, numeracy, and computer skills
  • Excellent verbal and written communication skills
  • Excellent organizational skills
  • Ability to identify improvement opportunities and drive implementation
  • Science-related degree
  • Computer System Validation auditing experience
  • Ability to train others in QA-related activities
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The Company
HQ: Akron, OH
783 Employees
Year Founded: 2005

What We Do

Our team helps medical device and pharmaceutical product manufacturers bring innovative, compliant and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA. Our experienced medical device and extractables and leachables (E&L) testing teams will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO. Smithers also supports the pharmaceutical industry and the development of biologics and vaccines from discovery through phase IV, with expertise that includes bioassays and high sensitivity assays. Our scientists have expertise in large molecule bioanalysis assay development, validation, and sample analysis.

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