Senior QA Specialist I

Why Patients Need You
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 Pfizer's dedicated and highly effective quality assurance team. You will evaluate and review Pfizer's commercial batches of drugs. You will ensure that product and process 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. As a QA Specialist III, 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 make complex issues easier to understand and build stronger alignment 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

• Ability to work in a fast-paced environment and be able and willing to juggle priorities as required.
• Review and approve laboratory and manufacturing incidents and investigations. Collaborate in development and implementation of CAPA .
• As needed, provide Quality Review and oversight of site cGXP documentation related to the support of manufacturing and Site/Engineering activities to ensure compliance with global regulatory agencies and Pfizer quality standards.
• Collaborate/independently engage with a wide range of co-workers, customers and management within PGS to gather the input and background knowledge needed to complete assignments.
• Anticipate issues and escalate to appropriate management attention immediately. Provide ongoing Site-based Ops support activities, on teams, in forums & support to site customers.
• Exercises judgment in resolving moderate to complex quality issues. Plans and executes work independently and consult with supervisor as needed, providing a recommendation for a solution.
• Know and apply technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.

Here Is What You Need (Basic Requirements)

• Applicant must have a high school diploma with at least 10 years experience, or an Associate's degree with at least 8 years experience or a Bachelor's degree required and at least 4 years of experience or a Master's degree with at least 2 years experience, PhD with 0+ years of experience in GMP Pharmaceutical or Medical Device Manufacturing environment or relevant regulatory experience (i.e. Board of Health) required.

Bonus Points If You Have (Preferred Requirements)

• Biology, Chemistry, Engineering, or related Technical Physical Science field of study preferred.
• Previous experience in QA strongly preferred.
• Previous experience in Manufacturing and/or QC preferred.
• Skilled at the use of Enterprise systems including, but not limited to:
• Site Quality management System (QMS), Laboratory Information Management System (LIMS), SAP and Pfizer document repositories.
• Experience with quality aspects of start-up of a manufacturing facility is helpful but not required.

PHYSICAL/MENTAL REQUIREMENTS
• Must be able to be present at the Andover site routinely as required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
• The position is first shift Monday through Friday. Some occasional off-hours (night/weekend/holiday) support may be required to support staff and operations.
• This is a hybrid role which requires personnel to be on Andover Site 2.5 days a week.
On a non-routine basis, personnel must be available on site 5 days a week under special circumstances throughout the year.
Work Location Assignment: Hybrid
Last Date To Apply: June 26, 2026
The annual base salary for this position ranges from $99,200.00 to $165,400.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. 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.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected] . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control