Job Description

Core Job Responsibilities: (These are the primary duties of the job, but the roles are expected to perform other duties as assigned)

Demonstrate safety as a value by performing all job functions safely, while also complying with corporate policies and departmental procedures, to reduce risk and eliminate loss.

Manages self in accordance with the Company values. Effectively achieve results that meet business and individual objectives.

Perform quality tasks in and outside of the lab including finished product, water, raw material, personnel, and environmental microbiological testing.

Participate in sanitization audits.

Perform computer data entry.

Create, review, and modify Quality work instructions and forms.

Create and review records of the Quality Management System (QMS) using Good Documentation Practices (GDPs).

Properly identify and react to quality issues.

Flow to work to support quality team needs.

Aseptically conduct microbiological testing in a timely manner.

Keep testing supplies, quality lab, storage, and work areas organized, clean, and sanitized (where applicable) to avoid cross contamination.

Receive and document receipt of quality supplies as well as retrieve, review, and record applicable Certificate of Analysis and/or Certificate of Conformance (COAs, COCs).

Record daily testing and activities using software (LIMS) and in various logbooks utilizing GDPs.

Perform verifications on calibrated equipment as needed.

Assist in validation studies as needed.

Conduct record audits. 

Maintain up to date knowledge regarding sector and facility converting and coform quality needs.

Provide feedback to appropriate personnel regarding the Good Manufacturing Practices (GMPs).

Have Operations shut asset down to correct immediate quality issues as necessary.

Other duties as business needs dictate.

Required Job Functions:

Role model all Safety Requirements including Electrical Safe Working Practices, Hazard Recognition, and Personnel Protective Equipment (PPE). 

Adhere to all Quality Requirements including strict Gowning and Hygiene requirements. 

Strong Analytical skills

Strong verbal and written communication skills

Ability to effectively influence others, possessing strong interpersonal skills, able to adjust communication style to different audiences.

Ability to utilize problem-solving skills to determine the root cause

Demonstrate initiative and self-motivation.

Demonstrate managing time and tasks efficiently while maintaining an excellent quality of work

Demonstrated performance in safety, quality, and attendance with previous employments.

Capable of prioritizing tasks to meet goals and ensure product quality.

Ability to develop a working knowledge of operational tasks required of Maumelle colleagues.

Required Qualifications:

Ability to maintain a work schedule of 12-hour flexible shifts (day or night), including overtime, weekends, and holidays (will be expected to work overtime as business needs dictate)

Must be able to wear the required PPE while performing tasks

Must be able to lift 40 pounds twice each hour.

Ascend and descend stairs, ladders and ramps.

Perform bending, twisting, stooping and crouching movements.

Understanding of GMPs

Minimum of 18 years of age

High school diploma or GED equivalency

Legal right to work in the United States

Preferred Qualifications:

Previous micro laboratory experience at an FDA regulated facility and/or degree in applicable science field

Previous LIMS will be consider a plus.

This position may require a post-offer/pre-hire Physical Abilities Test (PAT) to confirm that individuals are able to perform the essential functions of the job.