GxP Training Specialist

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.

Duties And Responsibilities

• Support the established strategic direction for the GxP training program
• Develop and deliver trainings on a variety of focus areas (but not limited to):
• Manufacturing
• Quality Control
• Quality Assurance/Quality Systems
• New Hire Onboarding
• Qualified Trainer Program
• Administer the Learning Management System (LMS)
• Uploads and archives training documentation in MasterControl as well as hard copies
• Creator/revisor of training or other quality system related documents
• Administers and maintains relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed
• Provides support to site personnel to ensure documentation requirements are effectively communicated, understood, and met, and that governing procedures are followed
• Serves as “Admin” with administrative rights
• Drive continuous improvement initiatives related to the GxP training program
• Partner with subject matter experts to determine the appropriate training methodology for new and revised documents
• Evaluate the learning needs of individuals, functions, and the organization to support staffing models
• Support regulatory inspections and corporate audits
• Ensure compliance with all regulatory standards, systems, procedures, and practices, including GxPs, and other regulatory requirements
  
  

Qualifications

• Minimum 3 years experience in a GxP biotech/pharmaceutical company or other similarly regulated industry
• Experience with adult learning and instructional design
• Experience serving as a qualified trainer and designing and delivering training to others
• Experience administering a Learning Management System (LMS), MasterControl preferred
• Strong facilitation and effective presentation skills
• Strong demonstrated knowledge of FDA and GxP requirements
• Strong written and verbal communication skills
• Ability to work as part of an integrated, global team and collaborate cross-functionally
• Ability to work onsite, as needed, to support business needs
  
  
  

Working Conditions

• Normal office working conditions: computer, phone, files, copier
• Production or laboratory facility
  
  
  

Physical Requirements

• Office environment
• Periods of prolonged sitting in front of a computer
• Frequently need to walk within the facility and engage with others as required
• Production or laboratory facility
• Gowning and PPE as required
• Physical ability to perform skill-based training
  

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Base Pay Range

$XXX,XXX - $XXX,XXX

Disclosure Statement

Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.