Analyst, Quality Control - Devices

Hispanic Alliance for Career Enhancement; Alzey; Vor Ort; EUR 40.000 - 70.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen sucht einen erfahrenen Analysten für Qualitätskontrolle, um seine wachsende Produktionsstätte in Alzey, Deutschland, zu unterstützen. Diese spannende Position bietet die Möglichkeit, an der Einführung neuer Technologien und der Einhaltung strenger GMP-Vorschriften zu arbeiten. Sie werden in einem dynamischen Umfeld tätig sein, in dem Ihre Fähigkeiten zur Problemlösung und Ihr Engagement für Qualität entscheidend sind. Wenn Sie eine Leidenschaft für die Verbesserung von Lebensqualität und die Unterstützung von Patienten haben, ist dies die perfekte Gelegenheit für Sie.

Qualifikationen

• Mindestens 3 Jahre Erfahrung in der pharmazeutischen Industrie mit spezifischer Qualitätskontrollerfahrung.
• Erfahrung in GMP-Produktionsumgebungen und in einem GMP QC-Labor.

Aufgaben

• Verantwortlich für die Durchführung analytischer Testmethoden und die Einhaltung von GMP-Vorschriften.
• Identifiziert und kommuniziert Verbesserungspotenziale in täglichen Arbeitsabläufen.

Kenntnisse

Qualitätskontrolle

Analytische Fähigkeiten

GMP-Vorschriften

Technisches Schreiben

Teamarbeit

Problemlösungsfähigkeiten

Detailgenauigkeit

Ausbildung

Bachelor-Abschluss in Naturwissenschaften oder Ingenieurwesen

Tools

LIMS

Empower

Jobbeschreibung

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Position Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Analyst, Quality Control - Devices, performs accurate and timely testing of routine lab samples and stability samples in accordance with appropriate GMP and safety guidelines, to support site production and stability requirements. The Analyst will perform laboratory testing associated with device attributes such as visual/functional and dose accuracy. The Analyst may be cross-trained to support chemical assays such as pH, UV-VIS, and Osmolality. The Analyst will review and interpret results and will perform second person verification (SPV) of analytical data. The Analyst utilizes technical skills to perform in-depth problem solving, support method transfer, proactively identify opportunities for continuous improvement, and assist in resolving laboratory investigations of atypical data and results.

Responsibilities:

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.

• Accurately performs analytical test methods and related support activities as per procedures or protocols.
• Accurately records data in reports or laboratory information management systems (LIMS) in accordance with laboratory procedures, standards, and GMP requirements.
• Recognizes deviations from procedures, methods, etc., and initiates investigations as required.
• Verifies (SPV) analytical data generated by other analysts within the lab as required.
• Identifies and communicates opportunities for improvement initiatives in daily work activities.
• Troubleshoots equipment and methods as required.
• Supports lean lab and 5S initiatives.
• Understands the scientific principles required for testing of drug substances and drug product, including the interaction of the chemistry and lab equipment.
• Provides technical support for non-routine (e.g., deviation) investigations.
• Maintains inventory of all supplies and consumables for the laboratory.

• Ensures compliance with current Good Manufacturing Practices (cGMPs) and maintains constant inspection-readiness.
• Ensures that data-integrity is maintained.

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 3 years in the pharmaceutical industry with specific Quality Control experience.
• On-site presence required.

Additional Skills/Preferences:

• Fluent in English and German.
• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Proficiency with applicable computer systems.
• Experience with a LIMS (Laboratory Information Management System) system and Empower.
• Experience in a GMP QC lab environment.
• Understanding of statistical tools and analyses.
• Experience with combination product device testing.
• Strong documentation skills and attention to detail.
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to work as a team.
• Root cause analysis/troubleshooting skills.
• Demonstrated attention to detail and ability to maintain quality systems.
• Proven ability to work independently or as part of a Team to resolve an issue.
• Technical Writing and Communication Skills.
• Previous regulatory inspection readiness and inspection execution experience.

Additional Information:

• Primary location is Alzey, Germany.
• Ability to travel (approximately 10%).
• Ability for Short Term Assignment (6-9 Months) in a Parenteral Products Network (PPN) established manufacturing site prior to starting the role.
• Ability to work overtime as required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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