Job Title: Microbiologist I

Job Description

Job Duties and Responsibilities:

1. Audit and test raw materials, R&D formulations, bulk product, finished products and the manufacturing environment against specifications and report findings in a value-added and timely manner.

• Conduct appropriate microbial testing (TPC, Indicator organism, PET, Gram stain, etc)

• on select chemical raw materials, all in process and finished product samples to monitor

• against limit specifications in a timely manner.

• Collect and evaluate production water system samples (USP grade, soft water, DI) to

• ensure compliance to specifications and take action as needed.

• Conduct environmental sampling of the facility and equipment (air samples, contact plates, rinse water and surface swabs) at prescribed frequencies and to support qualifications/validation studies.

2. Report results and ensure accurate and timely transition of quarantined raw materials, bulk product and finished products based on testing results.

• Communicate results to various departments/customers upon successful completion of testing to coordinate the timely release of product that has passed established specifications for shipment.

• Immediately report testing results that deviate from specification.

• Immediately make intervention to any potential non-conformance.

• Maintain control of “out-of-specification” material by moving it to a holding area electronically.

3. Validate procedures/processes, test methods, and equipment that the lab employs to detect and identify microorganisms to ensure compliance with customer and regulatory guidelines.

• Validate microbial recovery test methods (NV, suitability, etc.) to ensure validated methods are used for testing controlled articles (raw materials, bulk, filled product)

• Qualify various prepared microbial media formulations (growth promotion, media sterility, pH) to ensure suitability for testing controlled articles (raw materials, bulk, and filled product).

• Calibrate, monitor and maintain test equipment on a daily, weekly and annual basis.

4. Ensures the Microbiology laboratory operates safely & efficiently so customer and regulatory guidelines are met.

• Ensures all documentation pertaining to the Microbiology laboratory is recorded in a timely, detailed, accurate and cGMP compliant manner.

• Documents the receipt and accessions samples accurately and timely.

• Records daily testing results on appropriate forms accurately and timely.

• Maintain microbial cultures used for controls and product validation testing.

• Maintain multiple quality tracking spreadsheets to facilitate effective investigational efforts.

• Maintains lab cleanliness in accordance with established housekeeping policies and procedures.

5. Understand and maintain a culture of “lean action” within the department so that we live lean better than any organization.

• Implement and maintain standards and processes that eliminate waste throughout the department.

• Apply and utilize “lean tools” to permanently implement improvements.

• Institutionalize 5-S in all aspects of the department. (Sort, Straighten, Shine, Standardize, and Sustain)

Qualification and Skill Requirements:

Prior Experience:

This position requires 0-2 years of experience in a FDA regulated microbiology Laboratory; prefer a minimum of 6 months experience in a microbiology lab within the pharma, personal care, food, or cosmetics industry. The ability to work with people effectively as required.

Knowledge Requirements:

To be effective, this position requires the ability to multi task, demonstrate a sense of urgency, and the ability to organize. Microbiology knowledge normally acquired through a 4-year college degree in microbiology/biology (or a related science) or equivalent experience is needed.

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.