Use Your Power for Purpose

Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need. 

ROLE SUMMARY

The Sr. Associate, Operations Professional is responsible for supporting various activities that ensure the compliance and completeness of the Focus Factory’s documentation and processes. In this role you will collaborate with all functions in the Focus Factory on implementation of new or improved product/processes throughout the life-cycle management phases. You will closely partner with Quality on issue resolution including (root-cause analysis, deviations, CAPA development and execution, and documentation updates) and will lead continuous improvement activities as needed.

You will manage the manufacturing investigation process to ensure on time closure of a range of Manufacturing Investigations including leading and facilitating M1 and M2 analysis, identifying true root cause, ensuring effective CAPA’s are implemented and authoring reports which adhere to the QMS writing guide template.

You will drive efficiencies in the overall manufacturing system through leading project teams managing complex opportunities and leading initiatives to support the Focus Factory in reaching its goals. The position will lead and support necessary change control to facilitate these process improvements, as well as any documentation updates required.

This role may be a people leader.

It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.

ROLE RESPONSIBILITIES

• Managing people may be required

• Own documentation content for the focus factory and provide guidance on process improvement activities as needed.

• Manage the content, process, and structure of SOPs, SOJTs and batch records

• Lead projects that support improvements in the Focus Factory  

• Perform GMP area walkthroughs for inspection readiness, safety, etc. as needed

• Develop content for training plans and SOJTs

• Conduct risk assessments, APR trend analysis, and aseptic events management

• Execute complex change controls.

• Ensure on-time closures of QARs, ERs, complex change controls, and CAPAs

• Maintain compliance and best practices, including CAPA mitigation plans and compliance priorities for the focus factory

• Actively identify and implement improvements in manufacturing procedures or processes

• Ensure robustness of investigations through application of the DMAIC methodology by performing M1 and M2 in support of deviations to determine root cause and SMART CAPAs, including the Pfizer Human Performance interviews.

• Drive the identification and implementation of effective CAPAs to support reduction in deviations.

• Support regulatory inspections, internal audits and customer audits and respond to verbal and written inquiries.

• Participate in and support IMEX processes (Visual Management, Standard Work, CI).

• Ensure on-time closures, CAPA rates, quality deep dive metrics, and lot release

• Participate in developing and delivering learning curriculum trainings and SOJT updates

• Maintain compliance and best practices, including CAPA mitigation plans and compliance priorities for the focus factory

 BASIC QUALIFICATIONS

• Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associates degree with 6 years of experience OR a bachelors with 2+ years of experience OR Masters with 0 year of experience. 

• May work as part of a self-directed team requiring the ability to work well with others.

• The ability to plan and organize work under time pressures.

• Strong project management skills.  

• Strong experience with cGMP pharmaceutical manufacturing in area of production, quality assurance, technical services, or engineering.  

• Self-motivated and able to adapt to rapidly changing priorities.  

• Strong oral and written communication skills and the ability to effectively manage project timelines through direct and indirect influence.  

• Technical writing and problem-solving skills required.  

PREFERRED QUALIFICATIONS<