Quality Control Deviation Writer

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies.  Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!  

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