QC Manager - Quality Control Chemistry

1d1 day ago

Rentschler Biopharma

Laupheim, DE · Full-time · €70,000 – €95,000

About this role

Rentschler Biopharma SE is a leading contract development and manufacturing organization focused exclusively on client projects for biopharmaceuticals. The company offers customized full-service solutions for bioprocess development and production of complex biopharmaceuticals. Headquartered in Laupheim, Germany, with about 1,400 employees, it emphasizes sustainability as a UN Global Compact participant.

In this QC Manager role, handle analytical questions for incoming goods inspection and compendial methods while managing deviations, failure investigations, OOX, changes, and CAPA processes in an electronic document management system. Review and release lab results, represent the area in audits, and contribute to quality control systems for incoming goods analytics. Create buffer stability protocols, risk analyses, and documents for analytical instrument procurement and qualifications.

As an independent family-owned company, Rentschler lives by 'Many hands, many minds - ONE TEAM!' Open, respectful cooperation defines the working environment, prioritizing quality awareness, diligence, and responsibility. Diversity of talents pursues the shared vision of advancing medicine to save lives, especially for patients with rare and serious diseases.

Enjoy meaningful work making a difference for severely ill patients through vital medicines. Experience an inspiring, collegial atmosphere fostering collaboration and team spirit on site. Access personalized development opportunities with further training tailored to individual growth.

Requirements

Completed degree in Chemistry or comparable qualification
Several years of professional experience in quality control in GMP environment
Sound knowledge of current pharmacopoeias such as Ph. Eur., USP, JP
Knowledge of instrumental-analytical determination methods
Very good English skills in spoken and written
Knowledge of SAP, LIMS, and electronic document management systems
Economic and analytical thinking and acting
Communication strength, assertiveness, organizational talent, flexibility, and resilience

Responsibilities

Serve as contact person for all analytical questions in incoming goods inspection and compendial methods
Handle deviations, failure investigations, OOX, changes, and CAPA processes in an electronic document management system
Create and review GMP specification documents based on relevant guidelines such as Ph. Eur., USP, JP, customer- or supplier-specific
Review and final release of laboratory results
Represent the responsibility area in customer and authority audits and implement resulting corrective measures
Contribute to establishment and optimization of quality control systems for incoming goods analytics
Participate in project teams and represent the group
Create monthly reports on results, activities, KPIs, and problem areas

Benefits

Meaningful work as part of a company developing and producing vital medicines for severely ill patients
Inspiring work atmosphere in a collegial environment promoting collaboration and team spirit
Individual development opportunities with access to personalized further training