QC Specialist II

Job Responsibilities:

• Project Management Assist with projects and simple to complex technical activities associated with method improvements, method transfers, and possibly lab related activities
• Work to meet schedules, timelines, deadlines.
• Support staff on project teams.
• Work with internal departments, collaborators and partners concerning projects and commitments.
• Support coordination with customers to support multi-site operational activities.
• Assure and apply GMP throughout operations.
• Participate in group and project teamwork activities; project and process improvements.
• Meets scheduled performance of 95% on time.
• Assist in execution of projects such as method transfers, and method validations.
• Support simple to complex technical activities associated with products, control systems, health authority filings.
• Support methods monitoring and reference material replenishment and testing. Identify discrepancies, as applicable. ;

Skills:

• GMP
• Quality control
• Quality Control
• Method Transfers

Education/Experience:

• BS/BA degree and minimum 2-3 years of experience in commercial quality control, preferred.
• Education experience preferably in relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry.
• Knowledge of GMP quality control pharmaceutical systems strongly desired.
• Strong skills in detailed planning with cross-functional teams
• Ability to negotiate, influence, and make decisions in order to meet local, network, and global objectives and initiatives.
• Strong verbal and written communication skills, ability to organize and present information both formally and informally.
• Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in multiple analytical and/or biological test procedures.
• Routinely exercises sound judgment, reasoning and problem solving.
• Capable of working with moderate independence or under moderate supervision and planning priorities and supporting potentially multiple projects and teams.