Quality Assurance Specialist
Support the manufacturing facilities and support functions maintain their training requirements and needs by providing guidance and information on recommended training programs and providing routine customer service.
Deliver On-The Job Training as deemed appropriate by management to support business needs and mentor trainees to competent and confident performance of new tasks.
Develop, maintain and organize current and accurate training materials. This includes: On the Job Training, learning activities, handouts, checklists, worksheets, job aides and course evaluations and performance Qualifications.
Deliver and / or facilitate instructor led training on GMP, technical skills, functional topics and others as deemed appropriate by QA Management
In conjunction with cross functional stakeholders assist with performing training needs assessment, develop courses and evaluations as assigned to support the business.
Manage Training requirements, events and tasks in the eQMS (Master Control) for cross functional stakeholders. This may include training assignments for new hires or transitioned employees, new and revised documents or new programs.
Determine the impact of process changes to current training materials and propose project plans to manage the updates.
Assist with tracking of qualifications and training metrics by generating training reports.
Writes and revises QA Standard Operating Procedures (SOP) under minimal supervision
Assists with training related actions associated with delivery of training in support of Quality Events (QEs).
Perform other duties as assigned.
Basic eQMS/LMS system coordination, administration and/or data entry skills, preference to Master Control
Instructional Design knowledge, e-Learning Development capabilities and experience developing and delivering On The Job Training and assessment materials.
Highly knowledgeable and skilled at pharmaceutical operations, including but not limited to: gowning, aseptic practices, formulation, fill/finish.
Proficiency in MS Office including Word, Excel, Access and Visio
Excellent verbal and written communication skills required, ability to present training content in a 1-1 setting or to a larger audience
Detail oriented, exceptional organizational skills
5-10 year previous experience in GMP environment
Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment preferably aseptic manufacturing environment.
Experience working with cross-functional teams and a results driven team player
Ability to multi-task in a dynamic environment with changing priorities
Bachelor's Degree or equivalent related industry experience.
Preference to degrees related to science, adult education or pharmaceutical processing.
Able to translate ideas to actual concepts and processes
Able to train others
Proven ability to manage multiple projects (duties) simultaneously
Able to work in a highly technical environment with competing demands and priorities
Frequent reading, writing, and verbal communication
Must be able to travel between multiple production facilities in close proximity
Frequent Sitting for meetings, computer work, etc.
Ability to Stand, Lift, Bend, Stoop and/or Kneel for the presentation and/or delivery of Training (OJT) and/or Filing