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 Learn, qualify, and facilitate Powered Industrial Vehicle (PIV) training NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS This position works a flexible first shift schedule. Core hours are 7:30a-3p Monday-Friday. The remaining hours to complete a weekly 40 hour schedule may be before or after core hours. Overtime, weekend, and holiday work is rarely required to meet critical business or customer needs. Other Job Details: Work Location Assignment: On Premise Last day to apply: September 4th 1st shift The salary for this position ranges from $25.66 to $42.76 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - Michigan - Kalamazoo location. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected] . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers . Manufacturing
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