Senior Sterility Assurance Specialist

Essential Functions and Responsibilities

• Championing sterility assurance principals at the site in the areas of aseptic processing, and contamination control.
• Support the site compliance to the global microbial control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, clean-room management, microbiological methods and validations, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments.
• Assist with the design of the contamination control strategy.
• Develop and maintain the microbial contamination/Cross contamination risk assessment (HACCP).
• Develop and maintain the EMPQ strategy and provides oversight of the EM testing program for regulatory compliance and technical soundness.
• Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial controls.
• Act as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for microbiological testing including Rapid Microbial Methods (RMMs).
• Assist with relevant internal and external inspection responses/action items related to contamination control issues.
• Establishes and implements appropriate training programs in collaboration with training leads.
• Ensure alignment and harmonization regarding global microbiological/aseptic standards, policies, practices, procedures and compendial/regulatory requirements across sites.
• Plays a critical role in facility design and modification, cleaning and sanitization program, operator qualification, gowning certification, manufacturing support, training, investigations, inspections, and audits.
• Troubleshoots contamination related issues occurring in internal and external manufacturing sites.
• Support site QC in microbiology deviations, LIR, OOS, Change controls and CAPA records.
• Owns change control tasks associated with qualification or program revisions.
• Regular communication to senior levels of management for issues related to contamination control.
• Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
• Minimum Six (6+) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
• Demonstrate knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology. Knowledge and familiarity with Annex 1.
• Strong knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, quality control endotoxin, mycoplasma testing, and microbiological control strategy required.
• Broad knowledge of quality control for biologics with experience in microbial contamination control.
• Experience with microbiological risk assessments.