Jobs
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Quality Assurance Sr. Associate
Sanford, NC 27330
Permanent
Job Summary
- Job Title:
- Quality Assurance Sr. Associate
- Posted Date:
- May 5, 2025
- Duration:
- Permanent
- Shift(s):
-
09:00 AM - 06:00 PM
- Pay Rate:
- -
Description
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.
What You Will Achieve
In this role, you will:
- Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) .
- Identify and implement new processes and programs for quality improvement.
- Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
- Review and approval of site documentation including but not limited to, change controls, cleaning/process/equipment/laboratory validation, data records, SOPs, automation, engineering and maintenance document and technical reports associated with clinical and commercial processing and ensuring adherence to regulatory agency requirements, ICH Guidelines, Pfizer standards, policies and values in a timely manner.
- 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.
- Analyzing data to identify trends, patterns, and opportunities for improvement.
- Identify and solve business problems to improve efficiency and productivity.
Here Is What You Need (Minimum Requirements)
- Applicant must have a Bachelor's degree with at +2 years of experience; OR a Master's degree with 0+ years of experience; OR an Associate's degree with 6 years of experience; OR a High school diploma (or equivalent) and 8 years of relevant experience.
- Understanding of current Good Manufacturing Practices and relevant GxP regulations and standards used in the Industry.
- Good working knowledge of Microsoft 365 -Excel and Word
- Proactive approach to problem-solving
Bonus Points If You Have (Preferred Requirements)
- Experience in quality administered systems
- Experience with programming Python, SQL, NumPy, Mixpanel and Java.
- Ability to evaluate loads of information and extract data.
Physical/Mental Requirements
Strong organizational skills, attention to detail and able to manage different priorities
Ability to work effectively within own team and interdepartmental teams
Strong critical thinking skills
Able to sit and review documentation for long periods of time
Non-Standard Work Schedule, Travel, or Environment Requirements
- This role is standard day Monday through Friday work shift.
Other Job Details:
- Last day to Apply: April 15th, 2025
- Eligible for Relocation Assistance: No
- 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.