QC Senior Scientist

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.

QC Senior Scientist will be recognized as a technical expert and a scientific contributor. With the deep knowledge of the discipline, QC Sr. Scientist will be an active team member whose decisions impact the project. QC Sr. Scientist will be using scientific judgment to adapt standard methods and techniques by applying prior work experience. QC Sr. Scientist will be forecasting and planning resource requirements for project team.  QC Sr. Scientist creativity in developing novel processes and new ideas will be used frequently. QC Sr. Scientist will undertake mentoring activities to guide team members.  

What You Will Achieve

In this role, you will:

• Apply technical and functional knowledge to design experiments and independently complete work within own work group/ project team, working on multiple sub-projects in parallel.  

• Act as a technical and scientific resource within own project team/ discipline. 
• Perform tasks associated with maintaining and improving cGMP (current Good Manufacturing Practices) compliant Quality Control and/or Stability laboratories. 
• Apply discipline’s principles, appropriate procedures and leadership skills to develop action plans and contributes to executing toward individual, team and project goals. 
• Perform testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability. 
• Train junior colleagues and develop training plans and/or oversee training activities for groups.  
• Support audits and review/approve technical content ensuring both scientific merit and compliance to regulatory agency regulations and Pfizer policy and standards. 
• Design and create protocols related to compliant test method transfer and validation. 
• Organize reports and records related to equipment qualification/computer validation. 
• Assist with protocol non-conformance evaluations. ​
• Identify and seek out external resources (e.g. Parenteral Drug Association, International Society for Pharmaceutical Engineering) to build or enhance understanding of scientific discipline. 
• Collaborate/independently engage with a wide range of co-workers, customers and management within the network to gather the input and background knowledge needed to complete assignments. 
• Assess existing situations and suggest continuous improvements to increase compliance and innovation. 

Here Is What You Need (Minimum Requirements)

• Applicant must have a high school diploma (or equivalent) and 8 years of relevant experience; OR an associate's degree with 6 years of experience; OR a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience.
• Strong technical skills in method validation and testing
• Good knowledge of US, EU and ROW cGMP & GLP.
• Experienced with analytical lab equipment (FTIR, Microscopes, etc.).
• Deep understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
• Detail-oriented with robust knowledge of quality systems
• Effective written and verbal communication, as well as interpersonal skills

Bonus Points If You Have (Preferred Requirements)

• Relevant pharmaceutical experience
• Strong understanding of computer system hardware, infrastructure, and networks
• Experience with Laboratory Information Management Systems (LIMS)
• Proficiency in data analysis and interpretation
• Use of Scanning Electron Microscope (SEM)(i.e. JEOL), Raman Technology (i.e Hound)
• Particulate/Particle Identification expertise
• Knowledge of regulatory requirements and guidelines
• Strong problem-solving abilities
• Effective time management and organizational skills
• Ability to mentor and train junior colleagues

Physical/Mental Requirements

Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis.