Quality Assurance Senior Associate
About The Position
Rangam is seeking candidates for a Direct Hire role as a Quality Assurance Senior Associate with our client Pfizer, one of the world's largest pharmaceutical companies. Seeking candidates in Sanford, NC or willing to relocate. 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: Evaluate and review clinical and commercial product 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. Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed. 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.
Requirements
- High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
- Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
- Experience in quality administered systems
- Strong critical thinking skills
- Ability to work effectively within own team and interdepartmental teams
- Good working knowledge of Microsoft Excel and Word
- Proactive approach to problem-solving
Nice To Haves
- Strong organizational skills and attention to detail
- Experience with regulatory compliance and documentation
Responsibilities
- Evaluate and review clinical and commercial product 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.
- Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
- 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.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
Number of Employees
251-500 employees
