Manufacturing Operator I

Cambrex•Longmont, CO

4d•$27 - $33

About The Position

The Manufacturing Operator will properly operate solid dose manufacturing equipment to perform production of drug products. Personnel in this position will operate manufacturing processing equipment by following standard operations procedures and batch records in accordance with FDA cGMPs. The main focus for personnel in this position will be responsible to operate, set-up and break down production equipment, clean production areas and maintain consumable supplies.

Requirements

Mechanical aptitude is preferred
Moderate knowledge of manufacturing equipment for cGMP environment
Ability to wear Personal Protective Equipment (PPE). Understands and follows safety procedures and works in a manner to avoid injury to self and co-workers. Willingness to work with highly toxic and controlled substances.
Ability to conduct routine in-process testing and visual inspections and identify out-of-specification conditions.
Ability to work in a regulated environment (FDA/DEO/OSHA) and strictly follow procedures.
Effectively communicates both verbally and in writing. Ability to read and comprehend detailed written instructions.
Ability to clearly and concisely document al work activities in a timely manner utilizing existing forms and records. Writes legibly.
Perform basic math functions to include product accountability and material adjustment calculations and rounding. Basic computer skills.
Ability to move materials throughout facility using appropriate methods and equipment.
Operate machinery and read process control instruments to ensure proper operation. Identify operations problems when they occur.
Ability to clean rooms, equipment and tools for use in a cGMP environment.
Perform basic troubleshooting applications.
Provide basic training to other operators after learning a skill set.
Minimal interaction. On an as needed basis.
Exhibited leadership skill in individual area of expertise.
Must have the ability to work overtime when required.
Must adhere to attendance policy of Avista. Expected to arrive for shift on time and contact management immediately if unable to attend work for any period of time.
May directly interact with auditors during a scheduled inspection.
Ability to work effectively within a team environment.
High school diploma or equivalent with 0-5 years of experience in a regulated environment.

Responsibilities

Properly operates, sets-up and breaks-down production equipment.
Maintains cGMP suites readiness for manufacturing activities including consumable allocation, cleaning of work area and tools and equipment disinfection.
Performs minor mechanical maintenance of equipment.
Maintains consumable supply inventory.
Washes small utensils and glassware for department.
Properly performs drug product manufacturing, packaging and labeling activities under direct supervision.
Follows written procedures.
Distributes clinical supplies.
Clearly and accurately documents activities for production records and manufacturing equipment (production notebooks, cleaning logs, maintenance logs, etc)
Perform basic math calculations.
Assists with batch records for cGMP manufacturing under direct supervision.
Other duties as assigned.