Operations Training Coordinator
PfizerAbout the role
Use Your Power for Purpose
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members who understand the importance and impact of their role in Pfizer’s mission. You will help to ensure that patients and physicians have the medicines they need when they need them. The significance of your role cannot be overstated, as it directly influences the availability of essential medications. Your dedication and agility are crucial in maintaining the high standards of our manufacturing processes. By continuously striving for excellence, you contribute to the overall mission of delivering life-saving treatments to those in need. Your commitment to improving outcomes ensures that our breakthroughs reach the patients who depend on them.
What You Will Achieve
The Drug Product (DP) Compliance Specialist – Training I role is accountable for the design, development, scheduling, and evaluation of the training plan for an assigned production unit/s. In scope training includes (at minimum) site policies/systems, production functions, and equipment operations. The DP Compliance Specialist – Training I role supports training solutions that comply with Good Manufacturing Practices (GMP’s), Pfizer Quality Standards (PQS), Environmental Health & Safety (EHS) and external regulatory agency requirements with the partnership of the DP Units and leaders.
How You Will Achieve It
The colleague is expected to coordinate training requirements for their assigned operations units including the following responsibilities:
Perform administrative tasks in the Pfizer Learning Academy (PLA) to support the learning plan for their assigned operations unit(s)
Support curricula enrollments/removals, as requested by operations
Monitor pending and overdue training assignments using PLA reports
Organize and schedule training sessions to minimize overdue training within their units
Document training completions in PLA and coordinate with PLA Administrator, when necessary
Develop and revise unit training documents, materials, & curricula in partnership with area management designee and site training department (training transformation/efficiency projects and revisions to keep current)
Create and maintain training plan (progression) roadmaps and curriculum blow out documents with input from assigned operations unit
Function as a responsible person and/or approver for training document review and approval in the Quality Management System (QMS) change management (CM) system (currently QTS transitioning to Vault in July)
Performs Impact Assessments from training perspective for every Drug Product Standard Operating Procedure (SOP) revision in the QMS CM system
Author documents (e.g. On the Job Training (OJT), curricula, forms, checklists) using standard work and best practices for formatting and processing
Complete curricula reviews with their unit(s) to ensure proper enrollments are completed on a quarterly or more frequent basis
Partner with Operations to complete periodic curriculum content reviews, as required by SOP
Provide training deep dive at Operations’ Integrated Manufacturing Excellence (IMEX) Tier meeting at agreed upon intervals
Serve as Point of Contact for PLA troubleshooting and training process compliance questions
Monitor and facilitate Qualified Job Task Trainer (QJTT) program
Participate and support Environment Health & Safety (EHS) initiatives such as Good Catch program & Incident and Injury Free (IIF) cultural improvements
Identify opportunities for continuous improvement within DP compliance and participate in resolution activities such as brainstorming, piloting, and implementation
Observes production floor activities and training tasks to better understand potential opportunities for compliance support, provide real-time QJTT feedback, complete QJTT requalification, and make progress on training program improvements
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