Quality Lab Associate I

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists.

Meghna at (224) 369-4230

Hema at (630) 847-0275

Job Title : Quality Lab Associate I

Location : Cleveland, MS

Duration : 12 Months

Job Description :

Assignment is dedicated to pyrogen testing.

This testing is to expedite release of product to accommodate the fulfillment of orders that are currently in a backorder situation.

Looking for life cycle chemist that works in Microbiology laboratory doing endotoxin testing

Working experience in medical device or pharmaceutical environments.

Role Summary :

The team currently utilizes the Charles River Endosafe kinetic turbidometric test method, a widely used approach with a standard instrument for this type of testing. We are in the process of transitioning to the Seavers Eclipse chromogenic testing system. This work may also involve responsibilities related to validation activities. As the role focuses on pyrogen testing, it offers an excellent opportunity to support and contribute to validation testing. For individuals who are relatively new to the field, this position provides valuable hands-on experience and professional growth.

Job Responsibilities

Perform Bacterial Endotoxin Testing and on intravenous solutions, sets, devices, raw materials, and plant water

Use laboratory instrumentation, computer systems and software to collect and record data

Must be able to use standard software applications such as MS Office Suite

Perform analysis requiring Good Laboratory Practices and understanding of microbiological principles

Perform investigations utilizing problem solving and troubleshooting

Prepare and perform protocols

Investigate deviations and ability to write exception documents

Ensure regulatory compliance

Learn, understand and apply rigorous quality standards utilizing Standard Operating Procedures (SOPs) within a quality system

Complete and peer-review documentation

Complete all testing, including special projects / protocol testing in a timely and appropriate manner

Must perform all other duties and responsibilities as determined by supervision / management

Must have knowledge of both plant and department environmental health and safety regulations and comply with said regulations accordingly

Must be able to work off shift hours and some weekends

Must notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur

Must sustain a clean and safe work area using 6S principles

A strong understanding of GLP and the requirements of operating within a quality system regulated environment

Ability to work independently and within a regulated quality system environment.

Knowledge, Skill and Abilities

Computer competency, required

Ability to work independently

Good organizational and time management skills

Good oral and written communication skills.

Ability to handle multiple priorities in a fast-paced environment

Prior experience with Bacterial Endotoxin testing

Physical Requirements

Must be able to physically perform all assigned activities.

Required Education and Experience

B.S. Degree in Science (Microbiology, Biology, Chemistry or other life science degree with Microbiology or Biology, preferred)

Microbiological analysis or equivalent lab experience within coursework

Experience within a quality system, preferred

1-3 Years experience

Other Duties as Assigned

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the employee for this job.

Duties, responsibilities, and activities may change at any time with or without notice.

Overtime is worked as required.

Relocation is permitted; however, all associated expenses will be the responsibility of the candidate.

Interview Process : Phone screening, Face-to-face interview

About us :

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.