Job Title: QC Sterility AnalystJob DescriptionAssist with the development of sterility assurance principles at the site in the areas of aseptic processing and contamination control. Support site compliance with 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. Assist with the design of the contamination control strategy and the development of microbial contamination/cross-contamination risk assessments (HACCP). Provide oversight of the EM testing program for regulatory compliance.Responsibilities
Perform EM and Utility trending reports within deadlines for two sites in PA.
Support 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.
Participate in facility design and modification, cleaning, and sanitization programs.
Participate as microbiology SME in inspections.
Assist with troubleshooting contamination-related issues occurring in internal and external manufacturing sites.
Assist QC in microbiology deviations, LIR, OOS, Change controls, and CAPA records.
Initiate change controls associated with qualification or program revisions.
Regularly communicate to senior levels of management for issues related to contamination control.
Assist with continuous improvement and implementing best practices, ensuring compliance with SA-related regulations and guidance.
Perform regular GEMBA style assessments of the aseptic process on site to assess compliance of operations, including identification of deficiencies and providing real-time coaching to aseptic staff.
Perform routine audits of the manufacturing areas.
Author new and revised procedures for the Sterility Assurance department.
Essential Skills
Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
Ideally 3+ years of microbial identification experience within Pharma or Cell/Gene therapy (excluding food).
GMP experience.
Experience with rapid methods such as sterility (qPCR), endotoxin, or mycoplasma (qPCR) - at least one or two.
Knowledge of contamination control strategy and environmental monitoring data.
Environmental monitoring of cleanroom and air.
Technical writing experience for validation protocols and/or reports.
Additional Skills & Qualifications
Experience with microbial validation, contamination control, aseptic technique, bioburden, Biofire, mycoplasma, microbiology, biology, and qPCR.
Ability to analyze data and write validation reports and EM methods.
Work EnvironmentThis position involves working in both lab and office settings. The work environment includes regular assessments of aseptic processes and routine audits of manufacturing areas. The role requires adherence to GMP standards and involves the use of advanced microbiological testing equipment, including Rapid Microbial Methods (RMMs).About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.