Senior Specialist, Quality Systems

Description

Duties & Responsibilities

• Participates in the training approach for the site, ensuring all regulations (e.g., USDA) and Company policy and procedure requirements are met.
• Partners with people leader and subject matter experts to identify training needs and gaps and develop solutions to close these gaps.
• Influences as a technical resource and departmental SME for Training system related questions and topics.
• Delivers training on the Training process and system (e.g., LOS).
• Grants system access to employees as appropriate.
• Administers the electronic learning management system LMS (e.g., LOS):
  • Creates learning courses, curricula, assignment profiles, manages new and existing user accounts, modifies training due dates.
  • Executes the removal and/or update of training profiles as required by users in the Training System (e.g., LOS).
  • Escalates and liaises with LOS technical experts to resolve and remediate LOS technical issues.
  • Performs/identifies GAP analysis as needed.
  • Works within Quality Systems Team and cross-functionally to remediate and close GAP’s related to learning plans.
  • Delivers technical LMS customer support to site employees through development of local communications and trainings.
  • Provides support of regulatory authority inspections and audits for training topics (preparation, conduct and follow up activities / reporting – as applicable).
  • Performs trending and analysis of site’s Training system performance.
  • Supports Quality Management activities (e.g., metrics, strategic initiatives).
• Provides input to process improvement initiates to site management on ways to enhance or replace existing training based on role and responsibility.
• Provides guidance on all aspects of Change Control system for the site.
• Influences as a technical resource and departmental SME for Change Control system related questions and topics.
• Trains employees on the Change Control process and system (e.g., TrackWise).
• Performs trending and analysis of site’s Change Control system performance.
• Supports Quality Management activities (e.g., metrics, strategic initiatives).
• Performs review and approval of site Change Controls.
• Evaluates and determines the Quality Risk associated with each Change Control.
• Provides QA assessment and approval decision for Change Controls.
• Tracks and maintains Change Controls in TrackWise system.
• Follows up on outstanding change controls that have been requested to make sure they get closed out.
• Follows up with Change Control owners to make sure all new Change Controls are completed on time.
• Tracks KPIs tied to Change Management and provide updates to department management monthly.
• Responsible for monitoring projects tied to Change Controls and Training, and attending necessary meetings as required to provide QA input.
• Assists with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.
• Performs any other assignment related to with Quality Systems responsibilities.

Requirements

• Minimum of a bachelor’s degree in a science related field with three (3) years of Quality Assurance experience in Animal or Human Biologics or Pharmaceutical manufacturing.
• Excellent oral and written communication skills.
• Attention to detail imperative.
• Organization skills along with ability to manage time and work with little supervision.
• Ability to teach, coach or assist site regarding various systems.
• Ability to work cross-functionally and establish effective working relationships with other departments along with working independently, interacting with all levels of management.
• Decision Making & Delivering Results; analytical thinking.
• Proficiency with PCs and MS Office applications (i.e., Outlook, Word, Excel) required; familiarity with electronic Training and Change Control systems.
• Familiar with USDA 9 CFR and cGMP Regulatory requirements.
• Knowledge of quality assurance processes/systems.
• Knowledge of and/or experience working in a regulated environment (e.g., USDA, FDA, etc.) is a plus.