AstraZeneca Pharmaceuticals LP Technician, Inspection - Global Operations in West Chester, Ohio

Description:

The Technician, Inspection is a direct labor position reporting to a Process Execution Team (Inspections/Filling) Process Facilitator on the Manufacturing floor, which supports operations. This position will require working in various Controlled/Non-Classified areas. The Technician operates equipment, performs in- process monitoring, line clearances, OEE data collection, cosmetic inspection and completes batch record entries in accordance with cGMPs. Working hours Monday-Friday, 3:00pm-11:30pm.

Essential Job Functions:

  • Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.

  • Perform 5S activities and maintain organization of operating areas.

  • Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Be familiar with “Material Safety Data Sheets” for area chemicals.

  • Perform batch record and GMP documentation entries. Maintain records and/or logs as required in performance of job responsibilities. This will include mathematical computation where needed.

  • Knowledge of product security controls including controlled substance handling.

  • Responsible for outgoing quality level.

  • Some overtime will be required with prior notice to support business needs.

  • Be able to start up and make minor adjustments to machinery.

  • Computer on-line may require some data input. This includes SCADA and HMI entries.

  • Perform the duties of operating assigned machinery consisting of servicing machines with materials, removing finished materials from machine tables, and assuring smooth flow of product.

  • Perform visual and physical checks of in-process and finished materials as requested.

  • Be familiar with job related hazards. Report all discrepancies to process facilitator.

  • Perform all other duties with minimal supervision under the direction of the process facilitator or designee.

  • Knowledge of light material handling equipment (non-motorized lifts).

  • Perform inventory control and reconciliation activities, which may require use of SAP in a limited role.

  • Work with various printing devices including printing mats, ink-jet, etc.

  • OEE data collection either by manual method or knowledge of automated collection system.

  • Certified OJT trainer activities on the team, as needed.

  • Flexibility in cross training between packaging functions.

  • Responsible for assembling, disassembling and sanitizing various packaging equipment.

  • Familiarity with chemical handling and spill control procedures in connection with hazardous waste pick-up duties.

  • Assist mechanical staff with preventive maintenance procedures, as required.

Minimum Requirements:

  • High school graduate, vocational school graduate or equivalent

  • 1 Year of experience in a pharmaceutical or cGMP regulated environment

  • Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.

  • Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.

  • 20/20 vision (color) with corrective lenses, vision test performed on-site.

Preferred Background:

  • Prior production/product inspection experience

  • Experience working in a LEAN manufacturing environment

  • Knowledge of cGMPs and FDA policies/procedures

Internal/External Contacts & Customers:

  • PET staff

Required Competencies:

  • Ability to work effectively in a team environment

  • Candidate should possess the ability to work in a changing/demanding environment.