Use Your Power for Purpose

The Associate II Operations Professional is responsible for supporting various activities that ensure the compliance and completeness of the Focus Factorys 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 Manufacturing Investigations including leading and facilitating M1 analysis identifying true root cause ensuring effective CAPAs are implemented and authoring reports which adhere to the QMS writing guide template.

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

This role will report to the Manager Operations Professional within the Plant Supply & Logistics Focus Factory.

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

What you Will Achieve

• 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 small projects that support improvements in the Focus Factory

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

• Execute complex change controls.

• Ensure on-time closures of 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 perform M1 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).

Here Is What You Need

(Minimum Requirements)

• Applicant must have a bachelors degree with 0 years of experience; OR an associates degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant 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.

• 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.

Bonus Points If You Have

(Preferred Requirements)

• Drug Product operations experience highly desirable.

• Previous manufacturing experience in a technical role required.

• Experience authoring ERs and Change Controls

PHYSICAL/MENTAL REQUIREMENTS

• Ability to perform tasks such as lifting sitting standing walking bending

• Oversees data analysis to support business development continuous improvement and quality responsibilities.

• Candidate will be required to complete general gowning training and execute responsibilities according to GMP area specific procedures.

• Remains organized & positive in ambiguous and fast-paced rapidly changing situations

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• May include non-standard work schedules travel and adherence to safe work practices and procedures

• Available to provide on-call support during weekends and after working hours

ORGANIZATIONAL RELATIONSHIPS

Strong partnership with all roles within the Focus Factory as well as with the Quality Operations organization.

The annual base salary for this position ranges from $66500.00 to $110900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes 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 (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Manufacturing