QA Specialist I

Job Description

The Training Specialist contributes to the maintenance, delivery and improvement of the training program and courses to support all Cross Functional GMP stakeholders across PCI. The primary objective of the Training Specialist will be to focus on the delivery of the On-the-Job Training program to support aseptic and non-aseptic manufacturing operations. This position will play a key role in leading functional and technical training including support of the building of a robust training program to support the knowledge, skills and qualifications of the PCI operators. Maintain GMP training documentation to support personnel training needs via paper, training databases and Quality Management System.

Job Responsibility

Support the manufacturing facilities and supporting functions for maintaining 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

Requirements

2+ years of 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
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 skill

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QA Specialist I - Training

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