Use Your Power for Purpose

Everything we do every day is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and riskbased compliant quality culture is flexible innovative and customer oriented. Whether you are involved in development maintenance compliance or analysis through research programs your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizers dedicated and highly effective quality assurance team. You will evaluate and review Pfizers clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

The Quality Assurance (QA) Specialist II is responsible for ensuring that all products manufactured meet the highest quality standards. The QA Specialist II shall have fundamental knowledge of the principles and concepts of cGMPs of pharmaceutical manufacturing and the site production processes. The role ensures adherence to regulatory expectations and GxP.

The QA Specialist II will have direct quality oversight for Vials Focus Factory processes (Filling and Finishing). The QA Specialist II will collaborate with a wide range of crossfunctional business groups and management.

The QA Specialist II will have additional responsibilities to execute in addition to QA Specialist I responsibilities. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Be able to perform all QA Specialist I tasks including but not limited to:

• Batch record review

• Production / warehouse walkthroughs

• Perform review and approval of:

• Impact assessments (for Change controls and deviations incidents)

• Event reports (ERs)/associated CAPAs

• Change controls action items

• Conduct and write department ERs

• Participate in Method 1 meeting to provide quality oversite and support in the identification of true root cause and associated CAPAs for manufacturing deviations.

• Performs Aseptic Technique Observations with Aseptic coaches and Production Supervisors to support ongoing production/media fill process.

• Create and revise departmental Standard Operating Procedure (SOPs).

• Review and approve site SOPs.

• Escalate critical issues in a timely manner.

• Responsible for SAP product holds and market restrictions.

• Attend deviation Triage meetings and communicate/escalate as required.

• Review/Approve DI Equipment Audit Trail Reviews/Cal/PM reviews and routine validation activities as assigned

• Support onsite regulatory inspections and internal audits (eg: serve as audit strategist).

• Support Continuous Improvements (CI) initiatives to improve safety and processes and successfully utilize IMEx tools.

• Participate in daily tier meetings as assigned.

• Serve as a delegate to the QA Specialist Lead/Mgr.

• Provide training to QA Specialist I.

• Utilize systems related to QA activities such as SAP eQMS Trackwise RDOCS and Batch Tracker.

• Collaborate with a wide range of crossfunctional business groups and management to ensure site metrics are met.

• Support additional QA/Focus Factory activities as assigned

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelors degree with at least 2 years of
  experience; OR a masters degree with more than 0 years of experience;
  OR an associates degree with 6 years of experience; OR a high school
  diploma (or equivalent) and 8 years of relevant experience.

• Sound knowledge of current Good Manufacturing Practices.

• Good interpersonal skills selfstarter continuous improvement mindset.

• Strong oral/written communications skills.

Bonus Points If You Have (Preferred Requirements)

• Previous pharmaceutical experience

• Experience at a manufacturing site

• Experience writing and managing deviations

• Experience in production batch recordreview investigation of nonconformance root cause analysis and change control management

• Strong attention to detail excellent organizational interpersonal and communication skills (oral and written)

• Exhibit sound judgment and make accurate decisions based on company procedures and standards technical expertise and industry guidance or regulatory requirements

• Capable of rapidly absorbing technical data and ability to apply this knowledge to a pharmaceutical manufacturing environment.

Physical/Mental Requirements

• Specific area/grade gowning required

• Capable of residing in a controlled environment for more than three (3) hours.

• Capable of standing for periods of more than one (1) hour.

NonStandard Work Schedule Travel or Environment Requirements

• Must be able to support during production 24/7 or 24/5 as required

• Must be able to work offshift from 6a230p 117 pm 128pm or 311pm on occasionor alternative schedule to provide cover across dayshift

Other Information

Work Location Assignment:On Premise

Last Date To Apply: May 20 2025

The annual base salary for this position ranges from $80300.00 to $133900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 10.0% 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.

Quality Assurance and Control