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Operations Training Coordinator

Pfizer (Internaljobs)

Kalamazoo, MI, USonsite

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About this 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 

Here Is What You Need (Minimum Requirements) • High School Diploma or GED

• 4 + years of experience

• Strong oral and written communication skills

• Proficiency in current Good Manufacturing Practices (cGMPs)

• Experience in pharmaceutical manufacturing or a related field

• Ability to troubleshoot and resolve technical issues

• Strong organizational skills and attention to detail

• Capability to work independently and as part of a team

• Proficiency in using standard office software and manufacturing systems

• Demonstrated good oral and written communication skills  

• Proficiency in use of computers and Microsoft Office Applications (PowerPoint, Word, Excel, Outlook, Visio)  

• Ability to manage workload and gather information in a dynamic environment  

• Ability to facilitate activities for groups of 10 or more people.​  

Bonus Points If You Have (Preferred Requirements) • Expertise in training programs for pharmaceutical industry is strongly preferred.  

• Proficiency in use of Learning Management System and Quality Management Systems (Vault, QTS Trackwise)  

• Experience with instructional design for the development and delivery of effective classroom and computer-based training solutions  

• Knowledge of regulatory requirements and quality standards

• Familiarity with Pfizer's Learning Solution and Quality Tracking System

• Ability to adapt to changing priorities and manage multiple tasks

• Ability to train and mentor less-experienced colleagues

• Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity

    PHYSICAL/MENTAL REQUIREMENTS • Long periods of sitting in an office environment  

• Long periods of standing and traversing hard surfaces  

• PPE and gowning requirements in varied production environments, including qualification for Aseptic Processing Areas  

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