Sr. QA Associate

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 risk-based 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 to ensure compliance with established specifications. 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 relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Senior Associate Quality Assurance for Incoming Material you will be responsible for reviewing inspecting and evaluating all incoming materials receipts at the site/location to meet established procedure requirements. This role provides final disposition to the incoming material and performs ERP transactions related to that process. Additionally the role provides review approval and ownership of quality documents such as SOPs Change Controls CAPA and deviations. Also partners with colleagues from areas such as Supply Chain QC and provides guidance on quality issues while fostering a collaborative and Quality mindset environment. Your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

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

In this role you will:

• Support release of incoming materials for clinical commercial and contract manufacturing operations in accordance with cGMP regulatory and compliance standards.

• Ensure all the corresponding documentation is complete accurate and acceptable to support Material disposition after inspection.

• Make quality decisions in real-time according to regulations and procedures.

• Closely work with cross-functional areas to investigate material release concerns and support enrollment activities to meet or exceed timelines

• Support site internal and external regulatory inspections as needed

• Works independently and with minimal supervision.

• Approve investigations and change control activities related to incoming materials.

• Contribute to moderately complex projects managing time effectively and developing short-term work plans.

• Investigate and document Quality Assurance deviations escalating issues to the Quality Assurance Lead as needed.

• Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.

• Identifies and leads process improvements.

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 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

• Solid understanding of current Good Manufacturing Practices and the applicable GxP regulations and standards

• Proactive approach to problem solving and strong critical thinking skills

• Ability to work effectively within own team and interdepartmental teams

• Excellent communication and interpersonal skills

• Good working knowledge of Microsoft Excel and Word

Bonus Points If You Have (Preferred Requirements)

• Willing to lead by example and jump right in desire to get to root cause collaborative and active listener

• Effectively manages stressful situations able to focus on task at regardless of circumstances and stress induced pressure

• Strong organizational skills and attention to detail

• Experience with regulatory compliance and documentation

• Masters degree and relevant pharmaceutical experience with more than 1 year of experience.

PHYSICAL/MENTAL REQUIREMENTS

Ability to stand for 1-2 hours at a time sit for 2 to 3 hours at a time. Require working in an office setting
where sitting and computer usage would be the norm.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

This is a first shift position occasional shift work may be required to support manufacturing operations.
Limited travel for the position; no more than 5% traveling. It will be necessary to work in areas that require aseptic gowning.

OTHER JOB DETAILS

Last Date to Apply for Job: July 24 2025.

Referral Bonus Eligibility: YES

Eligible for Relocation Package: NO

Work Location Assignment:On Premise

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