Quality Control - Microbiologist

Express Employment Professionals; Birmingham (AL); On-site; USD 33,000 - 36,000; Full time

Job summary

Express Employment Professionals is seeking a Quality Control Microbiology Technician to support the Environmental Monitoring Program in an ISO Class-8 environment. You will monitor environmental data, document deviations, and apply approved microbiological techniques for analytical testing.

This role also manages incoming materials, labeling, and related QC tasks. The position requires two years of lab or cleanroom experience, familiarity with cGMP, and strong communication skills.

Qualifications

• Continued education in biology or a related field with at least two years of lab or cleanroom experience.
• Experience with cGMP guidelines and industry practices.
• Experience in production/manufacturing settings.
• Strong verbal and written communication skills and attention to detail.
• Ability to work independently and in a team; good computer skills.

Responsibilities

• Monitor environmental conditions (temperature, humidity, pressure) in production areas using appropriate instruments and document findings.
• Apply aseptic techniques and use PPE in ISO Class-8 environments.
• Sample and document results of third-party testing and environmental monitoring.
• Perform sampling for cleaning validations and verifications.
• Develop charts/graphs to present trends to QA teams and management monthly.
• Report out-of-spec results and participate in CAPA investigations and process changes.

Skills

Biology

Laboratory experience

cGMP knowledge

Attention to detail

Communication skills

Independent work

MS Office

Inventory software

Education

Biology coursework

Tools

ZenQMS

Inventory management software

Microsoft Office

Job description

Location: On-siteJob Type: Full-TimePay: $24.00 – $26.00 per hour DOEHours - M-F, 7:00am to 3:00pm

About the Company:

Express Employment Professionals is a leading staffing provider, proudly serving job seekers and businesses throughout the U.S., Canada, South Africa, Australia, and New Zealand. We’re dedicated to helping individuals find meaningful employment opportunities while supporting companies in building strong, dependable teams.

Position and Scope

The Quality Control Microbiology Technician supports the Environmental Monitoring Program, tracks trending environmental data, documents any deviations and is responsible for the application of approved microbiological techniques and methodologies used in analytical testing within an ISO Class-8 environment. The position will also perform other Quality Control functions such as managing the incoming materials program and label control, as assigned.

Essential Duties and Responsibilities

• Routinely monitor temperature, pressure, and humidity levels within the production rooms utilizing air samplers, growth and media plates, and environmental sensors and record findings using applicable software systems.
• Apply aseptic techniques in daily workload while donning personal protective equipment (PPE).
• Conduct sampling and documenting results of third-party laboratory testing, including submitting environmental monitoring plates, endotoxin testing, and quarterly inspection testing.
• Perform sampling for cleaning validations and verifications.
• Develop charts and graphs to display to cleanroom personnel and present trending of environmental monitoring data to Asteria Health Operations and Quality teams monthly.
• Report out-of- specifications (OOS) test results to management.
• Make recommendations to revise standard operating procedures and conduct change controls based on observations and findings.
• Assist with non-conformance investigations, deviations, and corrective/preventive actions (CAPA) related to contamination.
• Inventory and document the receipt of all incoming materials and supplies used for testing.
• Print, gather, and prepare the proper documents and specification sheets for incoming materials approval.
• Properly label and store approved materials for use, in accordance with applicable regulations, policies and procedures.
• Print product labels following the documented specifications for each product.
• Conduct routine cleaning and maintenance of the product label printer.
• Accurately document labeling activities for production batch records.
• Ensure segregation of labels of distinct lots and schedule with Production and Operations the appropriation of the labels for respective lots.
• Assist in training others to perform environmental monitoring using Standard Operating Procedures (SOPs) and Work Instructions as well as with personnel qualifications.
• Model gowning qualifications for staff working in ISO Class-8 rooms.

Skills and Experience Required

• Continued education in biology or a related field plus two years of experience working in a laboratory or cleanroom environment. A combination of education and experience, such as two years of experience in a microbiological laboratory or performing environmental monitoring in a cleanroom will also be considered.
• Experience working with cGMP guidelines and demonstrate expertise in a variety of the field’s concepts, practices, and procedures.
• Experience working in a production or manufacturing setting.
• Must exhibit excellent verbal and written communication skills.
• Must exhibit excellent attention to detail.
• Ability to work independently with minimum or no supervision and in a team environment.
• Good computer skills (data entry, Microsoft Office products, email, internet, ZenQMS, and inventory management software systems).

Additional Notes

• Must be able to gown for ISO 8 area and follow safe practices when working with Active Pharmaceutical Ingredients and microbiological organisms.
• Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time.
• Must be able to use necessary equipment such as computers, scanners, phone/headset, or other technological devices as assigned.
• Must be able to work in a team environment and be flexible to easily adapt to changes in assignments.