QC Senior Scientist

QC Senior Scientist

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

Responsibilities

• 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.

Preferred Qualifications

• 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