Job Title: Fill/Pouch Operators

Location: Marion, NC 28752

Duration: 12 months assignment

Shift: 12 hour shift 7pm – 7am & 7am – 7pm

Position Summary

1.       The Operator, Fill is an Hourly Non-Exempt position which contributes to our mission of saving and sustaining lives by inspecting, printing, filling and sealing flexible containers which hold IV therapies, premixed drugs, renal therapies and other sterile solutions.

2.       The Operator, Pouch is an Hourly Non-Exempt position which contributes to our mission of saving and sustaining lives by inspecting, over-pouching and performing quality checks on filled bags which hold IV therapies, premixed drugs, renal therapies and other sterile solutions.

Essential Job Duties (Duties performed on a rotational basis)

1.       Fill, assemble and plug flexible containers with solutions or premixed drugs at a rate consistent with production needs. Print labeling and bar code information on the flexible containers using a computerized printer. Maintain the printer by replacing printer foil, ribbon and by making minor adjustments. Supply the filling stations with printed bags and other supplies necessary to assemble the flexible container. Inspect and ensure that the printed bags and their components meet quality standards

2.       Over-pouch and seal the over-pouch, enclosing a bag containing solutions or premixed drugs, at a rate consistent with production needs. Inspect and ensure that the over-pouches, bags and their components meet quality standards. Perform scheduled quality checks using an assortment of gauges and a scale. Perform and document scheduled cleaning activities. Notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur. Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP). Sustain a clean and safe work area using 6S principles. Correct any over-pouch seal or packaging issues previously identified

Duties performed on a continual or intermittent basis

·         Perform and document scheduled cleaning activities

·         Perform scheduled quality checks using an assortment of gauges and a scale.

·         Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

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

·         Sustain a clean and safe work area using 6S principles

Work Environment

·         In a Class I/ Class III Controlled Environment which includes the following dress/gowning requirements: safety glasses, safety shoes, ear plugs, jumpsuit, hood, hairnet, beard cover, gloves, isolation mask and boots (additional PPE required when cleaning)

·         Constant or intermittent exposure to elevated levels of noise

·         Involves working around equipment, machinery and belts

·         Requires occasionally working with chemical cleaners and disinfectants

Required Qualifications

·         High School Diploma, GED or equivalent

·         Must be at least 18 years of age

·         Must have basic English written and oral communication skills adequate to communicate with other team members.

·         Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.

·         Must be able to perform basic mathematics

·         Possess or be able to obtain Inspector Certification

Preferred Experience (not required)

·         One year of manufacturing experience

·         CRC (Career Readiness Certification) Silver level

Physical Requirements

·         Requires continuous grasping, pushing/pulling up to 15 pounds and reaching with hands and arms.

·         Lifting and carrying on average up to 15 pounds frequently throughout the shift.

·         Normal visual acuity and the ability to distinguish color are necessary.

·         Have the ability to complete quick and precise repetitive processes using both arms and both hands

·         Occasionally specialized physicals are required when working with certain drug codes.

·         Must be able to squat, climb, reach above shoulder level, reach at or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist and balance

Other Duties as Assigned

·         Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are 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