QC Senior Scientist
- United States - North Carolina - Sanford
Use Your Power for Purpose
The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, and validation. Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; testing, analyzing, interpreting, and trending results; and creating, reviewing and approving documentation.
Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.
What You Will Achieve
In this role, you will:
- Acts safely and follows all EH&S safety requirements for site and QC laboratories.
- Be recognized as a “go-to” person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations and Pfizer policy and standards.
- Excellent written and verbal communication skills
- Ability to identify issues, present complex problems with possible solutions, and actively take a leadership role to resolve issues.
- Ability to solve highly complex mathematical problems and situation-dependent problems using convoluted information.
- Ability to receive feedback from management and colleagues and take accountability for actions and personal development.
- Aptitude for good decision making based on procedures, guidance, and experience.
- Awareness to know their own limitations and seek senior scientist or management guidance when appropriate.
- Desire to ensure correctness and accuracy in tasks and documentation.
- Fitness of functioning as a team member and performing independent work with minor guidance
- Willingness to use personal skills and knowledge to achieve individual and company goals and objectives.
- Understanding of own area of function and knowledge of other cross functional areas
- Able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching.
- Understands the importance of feedback and receives feedback well from management and other colleagues.
- Makes good decisions based on knowledge of quality systems and technical experience.
- Recognizes the impact of procedural changes that may impact future quality tasks and decisions.
- Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations.
- Responsible for personal timelines and seeks advice if conflicts arise.
- Interacts with business lines and shares information with team; capable of influencing and negotiating with business lines.
- Ability to communicate effectively with good interpersonal skills.
- Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Lead efforts to improve process performance, procedures and reporting to meet changing quality and regulatory compliance.
- Able to create, review, and approve compliant test methods and training materials.
- Perform tasks associated with maintaining Current Good Manufacturing Practices (part of GxP), compliant Quality Control, and Stability laboratories.
- Support preparation of reagents, receipt, storage and handling of reagents.
- Perform testing including but not limited to clinical and/or commercial product, raw materials, validation, stability, and Environment Monitoring samples.
- Support detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.
- Review and authorize all laboratory data and have an extensive overall knowledge of all laboratory operations.
- Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects.
- Perform various inspections of laboratories and surrounding office area as assigned and prepare a report.
- Participate in out-of-specification and failure investigations and recommend corrective actions and demonstrate problem solving abilities.
- Train junior colleagues and may develop training plans and/or oversee training activities for groups.
Here Is What You Need (Minimum Requirements)
- Applicant must have a Bachelors with at least 9 years of experience OR Masters with more than 7 years of experience or a PhD with 0+ years of experience.
- Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
- Fundamental understanding/use of laboratory instrumentation function and analytical testing focused on analytical methods (e.g. HPLC/UPLC, iCIEF/Maurice, Purity/PA800+, plate-based methods)
- Experience with Laboratory Information Management System (LIMS) and Data review
- Aptitude for good decision making based on procedures, guidance, and experience.
- Effective communication skills
- Knowledge of Microsoft Office applications, specifically Word and Excel
- Excellent effective written and verbal communication and interpersonal skills
- Ability to work in a team environment.
Bonus Points If You Have (Preferred Requirements)
- Experience defending laboratory practices in regulatory audits and Quality Operations
- Relevant experience in biotherapeutics (antibodies, vaccines, and gene therapy)
PHYSICAL/MENTAL REQUIREMENTS
- Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.
- Intellectual capability to perform complex mathematical problems and perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Work schedule is first shift (8:00 am to 4:30 pm) but can include weekdays and/or weekend days as appropriate for assigned tasks/activities. Minimal flexibility in work schedule to cover business needs. Minimal off-shift work to ensure business needs are met.
- Non-existent to minimal travel.
- Must be able to wear appropriate PPE (e.g., lab coat, safety glasses, non-porous shoes, gloves, etc.)
- Work Location Assignment: On Premise
OTHER JOB DETAILS
- Last Date to Apply for Job: April 14, 2025
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: YES
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)