QA Specialist I - Training

PCI Pharma Services•Bedford, NH

10d

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. 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.

Requirements

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.
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

Responsibilities

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.