Job Title: Quality Control Microbiology Senior Analyst

Job Description

We are seeking a Quality Control Microbiology Senior Analyst to perform testing and monitoring activities in support of the start-up and operation of the QC Microbiology laboratory and manufacturing areas.This is a 6-month contract role.

Responsibilities

• Demonstrate company values as part of a high-performing, people-focused, inclusive, and collaborative organization.
• Perform and review routine Quality Control laboratory work, including environmental monitoring, clean utility sampling and testing, microbiological material qualification and maintenance, bioburden testing, endotoxin testing, compendial testing, and container closure integrity testing.
• Generate and revise Quality Control documents according to established document management processes.
• Assist in the development of training materials and independently deliver training to staff for QC programs, systems, and processes.
• With management oversight, execute qualification/validation activities for QC laboratory equipment, instruments, and systems.
• With management oversight, execute internal and external method establishment (e.g., qualify, validate, verify, transfer) protocols to ensure QC readiness for production activities.
• Initiate and support microbial excursion investigations related to manufacturing plant monitoring programs (e.g., environmental monitoring, aseptic gowning, utility monitoring) through collaboration with other functions (Engineering, Manufacturing, MSAT).
• Apply and advance Operational Excellence/LEAN philosophy within the QC laboratories to ensure continuous improvement across all programs, processes, and systems.
• Prepare, ship, and track samples to outside testing laboratories.
• Provide additional support within the Quality organization, as needed.

Essential Skills

• Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with 2 years of experience working in a cGMP regulated QC environment.
• Experience with microbiology, quality control, environmental monitoring, laboratory practices, aseptic technique, chemistry, and cGMP.
• Proficiency in endotoxin testing, bioburden testing, raw material sampling, release testing, clean utility monitoring, TOC, LIMS, and QMS.
• Understanding of Operational Excellence/Continuous Improvement philosophies with practical application in a regulated laboratory environment.

Additional Skills & Qualifications

• Quality Control experience in an FDA-regulated industry supporting cGMP manufacturing areas.
• Previous experience working in laboratory and/or facility startup in a cGMP setting.
• Experience working in a clean room environment.
• Experience in cGMP cell and gene therapy manufacturing and/or testing facility.
• Experience implementing a Laboratory Information Management System along with associated processes and documents.

Pay and Benefits

The pay range for this position is $32.70 - $40.38/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Louisville,CO.

Application Deadline

This position is anticipated to close on Apr 7, 2025.

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.

Salary : $33 - $40