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GeneFab
Alameda, CA, United States
The Senior Associate, Training and Document Management is responsible for Document Control and Training Coordination activities in the Quality Systems team at GeneFab 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 f
Job Source: GeneFabActalent
Foster City
Seeking 1 Document Control and Training Specialist HYBRID role, onsite in Foster City, CA Description: • Authors administrative changes to department documents. • Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined pro
Job Source: ActalentActalent
Foster City
Description: • Authors administrative changes to department documents. • Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedures, and effective management and implementation of related documents. • Man
Job Source: ActalentActalent
Foster City
Description: • Authors administrative changes to department documents. • Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedures, and effective management and implementation of related documents. • Man
Job Source: ActalentActalent
Foster City
Description: • Authors administrative changes to department documents. • Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedures, and effective management and implementation of related documents. • Man
Job Source: ActalentActalent
Foster City
Description: • Authors administrative changes to department documents. • Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedures, and effective management and implementation of related documents. • Man
Job Source: ActalentActalent
Foster City
Description: • Authors administrative changes to department documents. • Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedures, and effective management and implementation of related documents. • Man
Job Source: ActalentActalent
San Mateo, CA, United States
Description: • Authors administrative changes to department documents. • Facilitates end to end management of the documents, including training requirements impact assessment, reviewing document content to ensure changes are appropriately following defined processes/procedures, and effective management and implementation of related documents. • Ma
Job Source: ActalentAlameda, CA, United States
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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Senior Associate, Training and Document Management jobs in Alameda, CA, United States
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