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West Pharma Laboratory Assistant - Quality Assurance/Control m/f/d 
Germany, North Rhine-Westphalia 
807682007

20.09.2024

Job Summary

In this role, you will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques. You will be assisting in developing procedures for instrumentation, test instructions, and test reports. You may coordinate the day-to-day receipt and shipment of samples in the laboratory and support the Laboratory team in administration & quality systems.

Essential Duties and Responsibilities

Perform analysis using various techniques and instrumentation including established and experimental test methods.

Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.

Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.

With guidance, assist in completing projects from protocol to final report.

Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.

Train new analysts as appropriate.

Exercises creativity in developing new test / debugging methods.

Keep current with new analytical technology.

Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.

Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.

Meet individual and departmental goals as required.

Support laboratory management in data quality-documentation, and archiving.

Maintain compliance to cGMP and ISO requirements.

May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.

May support in audit preparation if needed.

Basic Qualifications

  • Successfully completed training as a chemistry or biology laboratory technician or as a chemical engineering or biological engineering assistant

Languages

  • German speaker required
  • Bilingual speaker (German and English) is an advantage

Work Experience

  • No minimum requirement
  • 0 - 3 years of experience

Preferred Knowledge, Skills and Abilities

  • KSAs
  • Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
  • Method development and validation
  • Possess the ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
  • Willingness to learn and apply new analytical techniques
  • Able to follow directions and prioritize tasks
  • Excellent interpersonal, written and verbal communications skills
  • Proficient in Microsoft Office tools and capable to learn other software programs
  • Able to review regulatory code and learn safety standards
  • Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
  • Able to comply with the company’s safety and quality policies at all times

Travel Requirements

  • 5%: Up to 13 business days per year