Sterility Assurance Assessment Lead

3 weeks ago


Lexington, United States INTELLECTT INC Full time

Job Title:

Sterility Assurance Assessment Lead Location:

Lexington, MA

(Hybrid - Onsite 3 days a week, 2 days from home)

Job Description: Execution of a Current State GAP Assessment of the Contamination Control Program of the client from a Global and site-specific perspective. Delivery of Current State Contamination Control Findings Report Execution of microbial and/or cross contamination LOPA, HACCP &/or FMEA in identifying and assigning risk (RPN) of identified GAPs to define prioritization in overall CAPA Plan. Delivery of Corrective and Preventive Action Plan based upon risk to remediate GAPs identified in Assessment. Management and oversight of defined CAPA Plan with assigned Stakeholders at site; to drive delivery and promptly elevate concerns and/or roadblocks. Required Qualifications: Signification experience (7+ years) supporting site compliance to the global microbial/viral control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, cleanroom management, microbiological methods and validations including RMM, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments. Significant experience (7+ years) in a microbial contamination control role within the pharmaceutical or biotechnology industry. Signification demonstrated experience in development and delivery of risk based CAPA plans. Knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology Strong knowledge of microbiological and sterility testing (i.e. environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control strategy) Experience with oversight of aseptic processing and the associated international aseptic processing regulations. Experience with microbiological risk assessments and prioritization techniques (LOPA, HACCP &/or FMEA) Comprehensive knowledge of global GMP and biologic regulatory requirements Excellent oral and written communication skills with strong technical writing experience required. Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders to drive delivery of CAPA plans. Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.

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