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Laboratory Technician

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Winchester

On-site

GBP 30,000 - 40,000

Full time

Today
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Job summary

A leading pharmaceutical supplier in Winchester, England is seeking a Laboratory Technician. This role involves ensuring compliance with GMP standards, conducting routine tests on products, and overseeing manufacturing operations. Ideal candidates will have a Bachelor’s degree in a related field or equivalent experience in a GMP environment, alongside strong communication and technical skills. This position offers an opportunity to contribute directly to the quality of pharmaceutical products.

Qualifications

  • 2 years relevant work experience in a regulated GMP manufacturing environment.
  • Lean Six Sigma or ASQ certification preferred.
  • Ability to follow written and verbal instructions.

Responsibilities

  • Perform microbial swabbing for environmental monitoring.
  • Audit batch records for compliance.
  • Support customer complaint investigations.

Skills

Basic math and computer skills
Good communication skills
Documenting and handwriting skills
Sound decision-making skills
Good Laboratory Practices

Education

Bachelor’s Degree in related science or technical field with 2 years experience
High School Diploma with 4+ years experience

Tools

Laboratory instrumentation
Job description

Job Description

We are seeking a Laboratory Technician to join the company, a premier supplier, in Winchester KY US. While working in this clean, not climate-controlled facility you will have the opportunity to be directly involved in the evolution of the industry. Come work for a company that has been consistently recognized among the Best & Brightest Companies to Work For.

The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and client SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.

Specific Tasks, Duties and Responsibilities:
  • Recommend SOP and batch record changes as needed
  • Review proposed SOP revisions and provide feedback to management
  • Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
  • Perform room and equipment clearances per procedure following cleaning conducted by production.
  • Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
  • Maintain a full understanding of all client SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.
  • Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
  • Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
  • Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
  • Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
  • Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
  • Other assignments as needed within the scope of QA Associate training curriculum.
  • Assist in investigations for deviations by supporting data gathering and root cause analysis
  • Enforcement of GMP Compliance.
  • Promotes team work and good communication.
  • Provide training and coaching to manufacturing staff as needed
  • Support site process improvements (training, efficiency projects, implementation of CAPAs)
  • Supports customer complaint investigation by performing inspection of retains and complaint samples
Essential Skills and Experience:
  • Education or Experience: (Minimum required to perform job)
    • Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience.
    • Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment.
    • Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications.
  • Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements)
    • Familiarity with basic laboratory instrumentation
    • Safe work habits
    • Basic math and computer skills
    • Good communication skills
    • Ability to follow written and verbal instructions
    • Able to work with limited supervision for routine tasks
    • Excellent documentation and handwriting skills
    • Proficient reading and comprehension skills
    • Sound decision-making, technical and problem solving skills
    • Good time management skills
    • Expert technical writing and problem solving skills
    • Good Laboratory Practices

The Company is an Equal Opportunity Employer and is committed to creating an equitable and inclusive environment for all.

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