Urgently hiring an Quality Control Analyst for a growing CDMO cell and gene therapy company!Position Summary:The QC Environmental Monitoring Analyst will be responsible for performing various different microbiology testing methods including viable and non-viable air sampling, surface plating, endotoxin testing, bioburden testing and gowning within an ISO-5 regulated cleanroom.Job Description:
Participate in aseptic process qualifications, such as aseptic gowning and media fill reads.
Perform Bacterial Endotoxin and Sterility Testing.
Perform growth promotion testing of microbiological media.
Perform Environmental Monitoring on a routine basis.
Perform water testing including TOC, conductivity, and Bioburdens
Perform microbial isolation techniques and perform Gram stain identifications.
Send out samples to contract labs and track results/reports.
Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
Qualifications:
Bachelor’s degree in a Microbiology or relevant field; Minimum of 6-12 months of experience with environmental monitoring or within the biopharmaceutical industry or equivalent.
Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
Strong knowledge of microbiological test methods and philosophies.
Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review
Proficient with computer software with MS Office and LIMS (MODA experience preferred).
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.
