QA Specialist I

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.Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.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 ManagementIn 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 supervisionAssists with training related actions associated with delivery of training in support of Quality Events (QEs).Perform other duties as assigned.Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.Frequent reading, writing, and verbal communicationMust be able to travel between multiple production facilities in close proximityFrequent 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 FilingWork Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Interacts with all departmental staff at various levels of the organization, external clients and suppliersTRAVEL: Must be able to travel between multiple production facilities, occasional out of state travel possible < 10%Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.5-10 year previous experience in GMP environmentExperience 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 playerAbility to multi-task in a dynamic environment with changing prioritiesBachelor’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 ControlInstructional 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 VisioExcellent verbal and written communication skills required, ability to present training content in a 1-1 setting or to a larger audienceDetail oriented, exceptional organizational skillJoin us and be part of building the bridge between life changing therapies and patients.