QA Specialist II

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

In this role, you will:

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s commercial batches of drug substance material. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. You will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will provide input to investigations to ensure compliance with configuration management policies.

As a QA Specialist II, your focus on the job will contribute to achieving project tasks and goals.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

The QA Specialist II demonstrates sufficient depth of knowledge within own work area in order to perform hands-on routine QA tasks. This role supports Operations including batch record review, logbook review, document review, suite walkthroughs and disposition activities. Resolve routine quality issues related to product manufacture and testing with guidance/coaching. Project work, as needed, will also be expected.

Provides ongoing site-based Operations support for ongoing product manufacturing.

Supports QA on the floor.

Competent review of GMP documentation (for example: batch records, procedures, forms, logbooks) with increased complexity and associated simple deviations (CalOOTs and Events)

Able to resolve less challenging quality issues and make simple batch disposition decisions with guidance and coaching.

Able to review and approve documents in PDOCS with quality mindset.

Uses established QA procedures and methodologies to propose solutions for straightforward problems with guidance and coaching.

Makes decisions that require knowledge of quality systems.

Represents QA on various Teams with direction from management.

Exercises judgment in resolving simple quality issues.

Able to review executed batch documentation for technical content within own subject area and reference to applicable GMPs and regulatory expectations, make value-added comments.

Manages own workload with oversight by manager/peer.

Represents their quality records with Board of Health inspectors, with support of management, as needed.

Maintains inspection readiness and supports internal/external audits as needed.

Manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

Review and approve Manufacturing records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.

Ensure that all documents received in the batch release area reviewed for completeness and accuracy.

Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.

Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.

Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing operations.

Here Is What You Need (Minimum Requirements):

Applicant must have a Bachelor's degree with 0+ years of experience;

OR an Associate's degree with 4 years of experience;

OR a High school diploma (or equivalent) and 6 years of relevant experience

Previous experience in GMP Pharmaceutical Manufacturing Environment.

Ability to work in a team environment within own team and interdepartmental teams

Effective written and oral communication skills

Bonus Points If You Have (Preferred Requirements):

Experience in production batch record review, log-book review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management.

Experience in writing and managing deviations.

Physical/Mental Requirements

Must be able to be present at the Andover site routinely as required.

Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures asappropriate.

Non-Standard Work Schedule, Travel, or Environment Requirements

This role is Second Shift, 2PM -2AM, 12-hour rotating 3/2/2 schedule

Other Job Details:

Work Location Assignment: On Premise

Relocation Assistance: No

Last Date to Apply: 5/22/25

The annual base salary for this position ranges from $66,500.00 to $110,900.00. In addition, this position is eligible for participation in Pfizer’s 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 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 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.

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.

Quality Assurance and Control

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