Associate, GMP Training & Documentation Specialist

Position Summary:

Rocket Pharma is a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. We are seeking a motivated candidate who will be responsible for GMP training and document management. This is a key role in the continued expansion of Rocket Pharma’s GMP operations, providing our professionals with the understanding and tools they need to achieve our high standards quality and compliance. Curiosity, positivity, and goal-orientation are key success factors for this role.

Primary Responsibilities:

  • Develops training curricula that instill an awareness of job function requirements and expectations for quality and compliance.
  • Supports the organization in the development, issuance, implementation and maintenance of GMP documentation
  • Facilitates the life cycle of master documents including confirmation of training execution
  • Works with cross-functional teams to create process flow diagrams and other visualizations to improve understanding
  • Manages users, training and document content in the electronic quality management system
  • Serves as subject matter expert on curriculum development, training other trainers as needed
  • Leads classroom training and workshops and performs period reviews of training effectiveness.
  • Interacts and collaborates effectively with internal and external team members to solve problems and maintain compliance

Education/Experience and Skills Requirements:

  • Bachelor’s Degree and/or Master’s Degree in Life Sciences or Engineering
  • 5+ years of relevant GMP experience in pharma/biotech company
  • Well versed in cGMP/ICH/FDA/EU regulations and guidelines
  • Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint)

Desired Competencies: (Edit for job specific preferred qualifications)

  • Detail orientation, with strong communication and organizational skills
  • Capable of working with minimal supervision
  • Demonstrated ability to solve problems
  • Experience with instructional systems design (e.g. ADDIE) preferred 

Physical/Mental Requirements: (edit for job specific requirements)

  • Use of computer with regular requirement to sit, stand and use a keyboard
  • Ability to uphold the stress of travel

Location: Cranbury, NJ

Travel Requirements:  Some travel (<10%) may be required

EEOC

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

About Rocket Pharma

Rocket Pharma is a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. www.rocketpharma.com.

Interested in joining our team? Contact us today!

Resumes with cover letters may be submitted to careers@rocketpharma.com