Quality Infrastructure Training Specialist Job Responsibilities
Education & Qualifications
- Scan and record training records
- Review documents for GDP compliance, track movement of documents, manage corrections Assign training curricula
- Maintain and update training database
- File electronic and hard copy training records
- Implementation of specific training and development initiatives
- Training effectiveness improvement projects.
- Assist in the management of qualifications for trainers' database.
- Assist in the design and build of QA curricula.
- Perform organizational and administrative tasks in the Learning Management System Maintain the system for tracking and evaluating training compliance and analyze training trends.
- Distribute training related communications via memos, schedules, reports, BioWeb, etc.
- Ensure completion of department annual GMP training and perform GMP training as necessary.
- Review and understand documents (SOPs) related to training functions for multiple sites.
- Review and revise training related materials for current practices and applicable organizational changes as directed
- Participate in lean improvement activities involving safety, compliance, accuracy, and efficiency.
- Participate in interdepartmental training initiatives.
- Participate in internal and external audits and inspections as needed.
- Comply with cGMP Documentation & Operations
- Comply with safety guidelines
- BA or BS in a technical discipline preferred (biological sciences preferred but not required)
- 2+ years experience in a GMP regulated environment, preferably with knowledge or proficiency in quality control
- Organizational skills to coordinate multi-discipline projects.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Power Point.
- Experience and proficiency with Learning Management Systems software such as ComplianceWire a plus.
- Understanding and familiarity FDA & European regulatory requirements, guidelines, and recommendations.
- Proficient organizational, spelling, grammar, and typing skills.
- Understanding of complex systems.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.