Job Title: QC Sterility Analyst
Job Description

Assist with the development of sterility assurance principles 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.

ResponsibilitiesAssist 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 provide oversight of the EM testing program for regulatory compliance.Perform EM and Utility trending reports within deadlines for the 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 program.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 understanding/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 SkillsQuality controlMicrobiologySterility testingEnvironmental monitoringMicrobial validationContamination controlGMPQuality assuranceMycoplasmaMicrobiologyBiologyAseptic techniqueBioburdenqPCRBiofireAdditional Skills & QualificationsBachelor’s degree in a relevant discipline (biological sciences or equivalent).Ideally 3+ years of Microbial Identification experience within Pharma or Cell/Gene therapy.Experience with rapid methods such as sterility (qPCR), endotoxin or mycoplasma (qPCR).Contamination control strategy – familiarity with Environmental monitoring data and contamination control plans.Environmental monitoring of cleanroom and air.Technical writing experience – ability to analyze data and write validation reports and EM methods.Work Environment

This role operates within a lab/office setting. You will be part of a fast-growing team working on a breakthrough therapy with the potential to save lives by contributing to the development of a lead, late-stage TIL product candidate for metastatic melanoma, which has the potential to become the first approved one-time cell therapy for a solid tumor cancer.

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 for other accommodation options.