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PCI Pharma Services QA Specialist I - Training in Madison, Wisconsin

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.

JOB SUMMARY

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 DUTIES

  • 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.

PROFESSIONAL SKILLS

  • 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

EXPERIENCE

  • 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

EDUCATION

  • Bachelor’s Degree or equivalent related industry experience.

  • Preference to degrees related to science, adult education or pharmaceutical processing.

QUALITIES

  • 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

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

  • 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

COMMUNICATIONS & CONTACTS

  • Interacts with all departmental staff at various levels of the organization, external clients and suppliers

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

  • Not Applicable

TRAVEL

  • Occasional out of state travel possible < 10%

#LI-LL1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

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