Quality Control Microbiology Analyst II

Job Description

Job Description

Description : Position Summary

Position Summary

As the Quality Control Analyst II Microbiology, you will be responsible for supporting the manufacture of AAV Viral Vector Gene Therapy Drug Products through the performance of Environmental Monitoring sampling and microbiological testing of Raw Materials, in-process and finished drug product samples

Essential Position Requirements

• Perform Environmental Monitoring of Grade C / D Cleanrooms and aseptic filling isolators, including sampling of viable surfaces, viable air and non-viable particulates in a Phase III / Commercial GMP Manufacturing facility.
• Conducts routine sampling and testing of Clean Utilities such as Water for Injection and Clean Compressed gasses.
• Conducts bioburden / endotoxin testing on raw materials, buffers / solutions, in-process and release drug product samples.
• Provides input on SOP revisions and may assist in the creation and editing of procedures and work instructions.
• Works closely with manufacturing and QA to process specific environmental monitoring, product change over and facility restart / recovery activities.
• Isolate and sub-culture microorganisms for identification and routine trending.
• Compilation and trending of Environmental Monitoring data for reporting purposes.
• Report and investigate environmental monitoring excursions.
• Flexibility in following unique campaign requirements that may include off-hour and weekend work.

Additional Skills & Qualifications :

• Experience and Qualifications
• B.S. or A.S. in a Life Sciences discipline preferred and 2 years of relevant experience working in a cGMP environment.
• Experience working in cGMP Quality Control.
• Experience with Environmental Monitoring of Clean Rooms and Clean Utilities.
• Experience with USP and EP microbiological testing requirements for bioburden and endotoxin testing preferred.
• Understanding of Good Manufacturing Practices (cGMPs)
• Strong attention to detail and strong organizational skills
• Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• Ability to succeed in a team-oriented environment under very dynamic conditions

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.