The Quality Control Specialist, Sterility Assurance will have substantial experience Analyzing QC sterility assurance program in a Pharmaceutical or Biotechnology environment. The QC Sterility Assurance Analyst is a key support role.

Essential Functions and Responsibilities

• Assist with the development of 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.
• Assist with the development of microbial contamination/Cross contamination risk assessment (HACCP).
• Assist with the development of the EMPQ strategy and provides oversight of the EM testing program for regulatory compliance.
• Supports the APV strategy.
• Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial controls.
• Assist with the selection and qualification of laboratory equipment for microbiological testing including Rapid Microbial Methods (RMMs).
• Assist with alignment and harmonization regarding global microbiological/aseptic standards, policies, practices, procedures and compendial/regulatory requirements across sites.
• Participates in facility design and modification, cleaning and sanitization program.
• Participates as microbiology SME in inspections.
• Assists with the troubleshooting contamination related issues occurring in internal and external manufacturing sites.
• Assists QC in microbiology deviations, LIR, OOS, Change controls and CAPA records.
• Initiates change controls associated with qualification or program revisions.
• Regularly communicates to senior levels of management for issues related to contamination control.
• Assists with continuous improvement and implementing best practices (ensuring understanding/ compliance with SA related regulations and guidance.
• Performs regular GEMBA style assessments of the aseptic process on site to assess compliance of operations including identification of deficiencies and provide real time coaching to aseptic staff. Perform routine audits of the manufacturing areas.
• Authors new and revised procedures for Sterility Assurance department.
• Ability to work in a team environment and independently as required. Maybe required to work Holidays and weekends.
• Ability to evaluate technical data and write technical documents.
• Advanced data integrity knowledge and practices.
• Intermediate understanding of statistics, control charts, action, and alert limits.
• Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
• Minimum three (3) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
• Knowledge and familiarity with cGMP/ICH/FDA/EU Annex 1 compliance regulations and USP, EP and JP monographs for microbiology.
• Knowledge of microbiological and sterility testing, media fills, environmental monitoring, microbiology methods (endotoxin, mycoplasma, and sterility).
• Experience with microbiological risk assessments.
• Successfully interface with multi-disciplined teams.
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• High level of ownership and accountability
• Demonstrate sense of urgency; ability to recognize time sensitivity.
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders.
• Flexible and adaptable style with an eagerness to take on challenges.
• Problem solver who not only identifies issues but Analysts efforts to resolve them.
• Excellent oral and written communication skills with strong technical writing experience required.

Preferred Education, Skills, and Knowledge

• Advanced degree preferred.
• Experience with cell therapy products is a plus.

Salary Range: $100K-110K/yr+ Bonus and stock