Microbiological Analyst

Looking for highly experience and tenured Microbiology individuals that are familiar with FDA regulation and experience with documentation. For more information call (402) 997-7611

Description:

• Oversee all microbiological approvals and testing at third‐party laboratories for ALI‐PM and data retention
• Ensure ALI‐PM microbiology methods are aligned to reference standards such as USP <61> and USP <62> by performing method periodic lifecycle review in Master Control against reference
• Maintain a clean working environment
• Act as subject matter expert (SME) in developing microbiological topics training tools
• Provide training to other personnel in microbiological testing and data analysis
• Perform and assist in the update of microbiological reference lists for methods and microbial species programs
• Engage with all departments for continuous improvements in bioburden controls for both product and environment
• Perform and assist in out‐of‐specification and out‐of‐trend investigations
• Perform and assist with deviations and corrective and preventive actions
• Provide microbiology SME input during management review of the microbiology evaluation
• Maintain compliance with ALI‐PM’s policies and procedures
• As the workload demand changes for the department, additional responsibilities may be required

Skills:

fda, microbiology, Biologics, Biology, Gmp, haccp, pharmaceutical, food manufacturing, audit, continuous improvement, process improvement, method development, microorganism, compliance regulations, compliance management

Top Skills Details:

FDA, Microbiology, Biologics

Additional Skills & Qualifications:

• Bachelor’s Degree in Microbiology required, if they have a bio degree they would HAVE to have experience in micro prior
• Master’s Degree in Microbiology preferred
• Minimum of 5 years in a food/pharmaceutical microbiology laboratory required
• Production experience in a food/pharmaceutical manufacturing operation required
• Experience with the analysis of manufacturing process as it relates to microbiological attributes
• Advanced computer skills, including Outlook, Excel, Word and PowerPoint
• Strong verbal and written communication skills with the ability to establish collaborative working relationships

Experience Level:

Intermediate/Advanced Level

WHY ACTALENT:

• Work with a dedicated career partner specialized in your skill set.

• We advocate on your behalf so you get what you want and need out of your job.

• Get performance feedback, career advice, and access to ongoing professional development tools.

• Build your career and learn new skills through projects as diverse as your curiosity.

• You are eligible for benefits, paid-time-off, and competitive wages that are paid weekly.

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

ABOUT ACTALENT:

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.

Actalent is an equal opportunity employer. If you have any additional questions feel free to reach out to me at JARAGON@ACTALENTSERVICES.COM. We have many other roles similar to this and additional scientific positions in the Omaha, NE and Lincoln, NE area as well as across the US.

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

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.