Senior Associate, Training and Document Management

4 weeks ago

Alameda, United States Enigma Search Full time

The Senior Associate, Training and Document Management is responsible for Document Control and Training Coordination activities for the Quality Systems team while complying with company and regulatory requirements. This function supports GMP training and documentation and will be expected to interact with personnel across all levels and functional areas.


Responsibilities

  • Responsible for assigning, releasing, and closing training items/records. Ensures document accuracy, quality, and data integrity
  • Train users in company quality systems; troubleshoot and resolve system issues and provide user support as well as support with system updates and enhancements to quality systems
  • Prepare training materials and coordinate sessions individually or in groups. Ensure appropriate content and format of GMP documentation and training materials
  • Coordinate with hiring managers to develop, update, and maintain training plans for new and existing employees
  • Author and administer GMP records including Standard Operating Procedures (SOPs), employee training plans, training materials, forms, templates, and other controlled documents
  • Assist in identifying training needs, design, maintain and implement training programs, and evaluate effectiveness
  • Report quality metrics pertaining to training activities
  • Support both internal and external audits, CAPA, Deviation, and Effectiveness Checks that involve employee training
  • Other quality related duties as identified by management


Qualifications

  • Bachelor’s degree in biology, chemistry or related field, or equivalent experience is required
  • 5+ years in an FDA regulated industry, preferably gene and cell therapy or biopharmaceuticals
  • Strong proficiency in MS Word, Smartsheet
  • Knowledge of GMP documentation lifecycles and requirements for each phase of the document
  • Prior experience working with electronic quality management systems, Veeva QualityDocs and Vault Training administration experience preferred
  • Must be meticulous, detail oriented, and analytical
  • Ability to build strong working relationships with cross-functional departments
  • Must be highly motivated, have excellent organizational, communication, and interpersonal skills
  • Must be able to work independently and as part of a multi-disciplinary team in a dynamic environment
  • Salary and Benefits: The hourly pay range is between $55-60 per hour; starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity
  • This is a contract position and not eligible to receive company benefits

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