Chemical Analyst

ConvaTec Inc

Shotton

On-site

GBP 28,000 - 45,000

Full time

3 days ago
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Job summary

ConvaTec Inc. is seeking a detail-oriented laboratory professional to uphold GMP/compliance in a challenging manufacturing environment. The role emphasizes analytical testing, data analysis, and continuous improvement within an ISO/FDA-regulated setting.

You will define processes, maintain equipment and calibration, and mentor technicians while ensuring timely delivery of quality products. This position requires cross-functional collaboration and strong documentation skills.

Responsibilities

  • Define activities, processes, and standards to meet quality requirements for manufactured materials, components, or products.
  • Build and maintain infrastructure and systems to ensure timely delivery of quality products.
  • Audit, monitor, and determine quality against internal and regulatory standards.
  • Report and troubleshoot deviations and defects in finished goods.
  • Provide assistance and training to lower level employees; handle non-routine problems requiring analysis.
  • Maintain calibration and maintenance schedule for analytical chemistry equipment.
  • Initiate out-of-spec investigations with Senior Analyst or Laboratory Team Leader as needed.
  • Follow validated methods and approved lab techniques; perform routine calculations.
  • Collect and trend data; report trends to Senior Analyst/Laboratory Team Leader.
  • Maintain laboratory metrics and waste disposal per EHS guidelines.
  • Utilize SAP to facilitate product release.
  • Ensure GMP and EHS compliance.
  • Perform analytical testing for in-process and finished product.
  • Support testing requests and project work.
  • Identify and deliver continuous improvement opportunities site-wide.
  • Support method validations per analytical chemistry method schedule.
  • Adhere to legal, corporate and site legislation.
  • Maintain equipment in a validated state; perform physical testing when required.
  • Participate in a quality system in a complex, regulated manufacturing environment.
  • Gain experience with data management and interpretation.
  • Maintain excellent written skills for reports and quality documents.
  • Demonstrate ability to work in a cross-functional environment and adapt to changes.
  • Knowledge of ISO standards and FDA regulations.
  • Knowledge of CI/QA methods and techniques.
  • Coach and mentor laboratory technicians.

Job description

Key Responsibilities

Requires broad knowledge of operational procedures and tools obtained through extensive work experience and may require vocational or technical education. May require the following proficiency:

  • Defining and specifying activities, processes, and standards to fulfill the quality requirements for a manufactured material, component, or product
  • Building and maintaining the infrastructure and systems necessary to consistently ensure the timely delivery of quality products
  • Auditing, monitoring, and determining the quality of manufacturing processes and/or outputs against defined internal and regulatory standards
  • Reporting and troubleshooting manufacturing process deviations and defects in finished goods
  • Works under limited supervision for routine situations. Provides assistance and training to lower level employees. Problems typically are not routine and require analysis to understand.
  • Maintain Calibration and equipment maintenance schedule of all analytical chemistry equipment.
  • Initiate laboratory out of specification investigations, include Senior Analyst or Laboratory Team Leader where necessary.
  • Follow validated methods, use approved laboratory techniques, and perform routine calculations.
  • Collect and trend data, and report trends to Senior Analyst/Laboratory Team Leader.
  • Maintain laboratory metrics.
  • Maintain waste disposal in line with EHS guidelines.
  • Utilise the SAP business system to facilitate product release.
  • Compliance with GMP requirements and uphold these standards.
  • Compliance with EHS requirements and uphold these standards.
  • Perform analytical testing for routine in-process analysis and finished product.
  • Support the request testing and project work.
  • Seek and deliver CI opportunities across the site.
  • Support method validations to adhere to the analytical chemistry test methods schedule.
  • Adhere to legal, corporate and site legislation.
  • Maintain operational equipment within a validated state.
  • Perform physical laboratory testing when required.
  • Successful participation in a quality system in a complex and regulated manufacturing environment.
  • Exposure to data management and interpretation of the data sets.
  • Excellent written skills which have been used to author both technical reports and quality documents (specification and procedural based).
  • Demonstrates working in a fast-paced environment where changes are embraced and implemented.
  • Demonstrated ability to effectively work and communicate in a cross-function environment.
  • Knowledge of ISO standards and FDA regulations.
  • Knowledge of continuous improvement/quality assurance methods and techniques.
  • Coaching and mentoring of laboratory technicians.
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