Laboratory Assistant – Quality Assurance/Control (m/f/d) in Stolberg, Germany

Laboratory Assistant – Quality Assurance/Control (m/f/d)

Requisition ID:
67083

Date:
Sep 20, 2024

Location:

Stolberg, North Rhine-Westphalia, DE

Department:
Laboratory

Description:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Where possible, please submit your CV in English.

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

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

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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.

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

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

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

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Train new analysts as appropriate.

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Exercises creativity in developing new test / debugging methods.

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Keep current with new analytical technology.

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

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

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Meet individual and departmental goals as required.

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Work collaboratively with other technical experts, and laboratory management.

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

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Maintain compliance to cGMP and ISO requirements.

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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.

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May support in audit preparation if needed.

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May handle Test Requests – write, review, and approve, and maintain traceability of samples.

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

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.