Sr. Quality Assurance Specialist
- United States - North Carolina - Sanford
Use Your Power for Purpose
Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
The position provides Quality Assurance oversight for Quality Control (QC). Provide QA (Quality Assurance) review and approval of Quality method validation / QC equipment qualification, QC protocol, reports, QC process control document, new and existing procedures, and Quality Control deviation/investigations. Leads triage using trend activities. The role might need to act independently to help identify process improvement and facilitate the implementation.
What You Will Achieve
In this role, you will:
Work to develop and implement quality assurance procedures and guidelines to support the Quality Control team’s testing and evaluation efforts.
Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol amongst others.
Provide final QA approval on more complex change control, effectiveness check, CAPA implementations, compendial assessments, and other documents associated with the business unit.
May also review and approve Deviation, complaints investigations, Laboratory investigations (OOS/OOT/OOE), and other Quality Events/Lab Events, Electronic build Master Batch, or any electronic record when needed, and all associated with compendial changes.
Drives compliance, efficiency, and process improvement projects.
Capable to make complex quality decisions in real time according to regulations and procedures.
Interfaces with internal partners to resolve technical issues.
Perform other duties as assigned and take ownership to support the implementation of activities needed for the start-up.
Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
Approve investigations and change control activities to maintain compliance with configuration management policies.
Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
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.
Here Is What You Need (Minimum Requirements)
BA/BS degree in Biology, Chemistry, Micro and Bioanalytical with 2+ years of experience OR MBA/MS degree in Biology, Chemistry, Micro and Bioanalytical with any years of relevant experience OR Associate’s degree with 6+ years of experience OR High school diploma (or equivalent) with 8+ years of experience.
Experience in Quality Control Laboratory (e.g., transfer, equipment qualification, analytical testing, stability, etc.) cGMP’s Laboratory environment (Pharmaceutical industry)
Familiarized and experience in Pharmacopeia requirements (e.g., USP, JP, EMEA amongst others)
Experience or familiarized with Data Integrity requirements
Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
Strong critical thinking skills, problem solving and analytical skills
Attention to detail and ability to work independently
Ability to work effectively within own team and interdepartmental teams
Good working knowledge of Microsoft Excel and Word
Provide excellent communication writing and analytical skills
Bonus Points If You Have (Preferred Requirements)
Experience in quality administered systems
Strong organizational skills and attention to detail
Experience with regulatory compliance and documentation
Ability to mentor and review the work of other colleagues
Proven ability work in a team environment through conflict resolution and negotiation
Physical/Mental requirements
Ability to work in a fast-paced, dynamic environment
50% on the floor time (walking/standing)
Able to manage different priorities
Occasionally lift and or move object up to 30 pounds
Stand / walk during the entire length of the shift
Visual abilities including near and far sight, color, peripheral vision, depth, and ability to focus
Gowning is a requirement of this position as is the use of the other PPE (Personal Protective Equipment)
Non-Standard work schedule, travel or environment requirements
Regular Business hours or shift schedule
Other job details
Last day to apply: April 16th, 2025
No relocation support available
Employee Referral Bonus eligible
Work Location Assignment: On Premise
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.
Breakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Global Supply
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
With an unwavering commitment to ensuring the availability and accessibility of these life-saving medications, we play a pivotal role in reaching patients, healthcare professionals, and markets across the globe.
Our network of state-of-the-art manufacturing facilities, strategically located distribution centers, and streamlined logistics systems enables us to deliver Pfizer's medicines with utmost efficiency and reliability, making a tangible difference in patients' lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)