Sr QC Research Associate II/III

Job Description

This position requires a highly motivated and knowledgeable associate to support the QC Technical Services group in Microbiology and Chemistry-related projects across multiple sites. Responsibilities include identifying and procuring new equipment and technologies, coordinating feasibility studies, developing and validating methods, supporting manufacturing investigations, and contributing to regulatory submissions (INDs, BLAs, NDAs, ANDAs) and audits. The associate will provide technical support for existing in-process and release assays, assist with the introduction of Rapid Methods, and offer scientific and validation input for instrumentation implementation, method transfers, and other compendial tests. Cross-functional collaboration with departments such as Manufacturing, Process Development, Validation, and Quality is essential to support site validation studies, microbial studies, and new product implementation.

Responsibilities:

• Lead specific aspects of a project, guide solutions for difficult problems, execute project tasks. Identify best solutions based on project requirements.
• Write, revise or review equipment and method qualification protocols/reports, engineering studies, SOP’s, specifications, and assigned sections of regulatory filings.
• Write or review deviation investigation reports and audit responses.
• Establish and manage relationships with equipment vendors and contract laboratories.
• Serve as subject matter expert for training, operation and troubleshooting of select laboratory instrumentation and procedures
• Serve on special committees and project teams
• Performs backup support microbiological testing activities as needed.
• Participates in compliance audits, investigations, and CAPA implementation. Participates in resolution and approval of microbiological excursions.
• Supports manufacturing and validation activities including Aseptic Process Simulations/Validations and Cleaning Validations.
• Develops and maintains effective working relationships with key internal/external customers.

Qualifications:

• BS in science related field
• 4+ years’ experience in pharmaceutical manufacturing or equivalent
• Able to work autonomously, receiving general instructions on new assignments.
• Strong technical knowledge of microbiological/ Chemistry test instrumentation and method development / validation including software/computer system validation.
• Experience with the execution and validation of test methods for sterile and non-sterile drugs, their raw materials, components and in-process testing. This includes the methods described in USP Chapters and relevant informational chapters.
• Knowledge of current compendia requirements.
• Excellent organizational, planning and scheduling skills. Capable of managing/coordinating multiple projects and priorities in a dynamic environment while maintaining a professional demeanor.
• Demonstrates a systematic approach to problem solving; considers all relevant facts & data when making decisions; applies previous experience & best practices to new situations.
• Owns the results of their individual actions & team activities. Ability to learn from mistakes & holds a strong belief in continuous improvements, both personally & professionally.
• Able to quickly change direction when business priorities or customer requirements change; exhibits a high level of flexibility when confronted with new or unexpected circumstances
• Good verbal and written communication skills; confident presenter, clear, concise technical writer.
• Familiar with common MS Office software packages.