Job Description

Advancing medicine to save lives. Together.

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

We are seeking a highly skilled and experienced Quality Control Deviation Writer to join our team. The individual will be responsible for investigating, writing, and resolving GMP deviations in a timely manner, ensuring compliance with regulatory requirements, and maintaining the highest standards of quality in our operations. The QC Deviation Writer will demonstrate flexibility and work effectively in a fast paced, rapidly changing CDMO environment. They are self-motivated, accountable, inquisitive, and have excellent organizational and communication skills. They can multi-task, while delivering excellent customer service.

Join our QC team with a quality mindset first to help make and release medicines for better lives. Our team is built on trust, respect, and integrity. The quality mindset is about operating with reliability, efficiency, and honest feedback.

Duties and Responsibilities

• Investigate, write, and resolve GMP deviations in a timely manner, in accordance with established procedures and regulatory requirements
• Develop and implement corrective and preventive actions (CAPAs) to address identified deviations and prevent recurrence
• Conduct root cause analysis to identify the underlying causes of deviations and implement corrective actions to prevent recurrence
• Ensure that all deviations are documented and tracked, and that appropriate records are maintained
• Collaborate with cross-functional teams to ensure that deviations are resolved in a timely manner, and that corrective actions are effectively implemented
• Maintain a thorough understanding of current GMP regulations, guidance documents, and industry best practices
• Participate in internal and external audits, as necessary
• Continuously improve the deviation investigation process by implementing best practices and innovative solutions
• Perform metrics to assess the performance and effectiveness of the QMS system as it relates to QC records
• Other technical writing may be required such as Change Control, validation protocols/reports, QC technical reports, and other technical writing tasks as assigned

Qualifications

• Bachelor's degree in a scientific discipline
• Minimum of 3 years of experience in technical writing/ deviation investigation within a regulated GMP environment (pharmaceutical, biotech, or medical device)
• Strong knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH regulations and guidelines
• Experience with root cause analysis and CAPA development
• Excellent analytical, problem-solving, and communication skills
• Ability to work independently and in a team environment
• Strong attention to detail and organizational skills
• Ability to manage multiple projects and priorities simultaneously

Working Conditions

• Normal office working conditions: computer, phone, files, copier
• Will interact with other people
• Pace may be fast and job completion demands may be high

Physical Requirements

• Frequent sitting for extended periods to use computer