AstraZeneca Pharmaceuticals LP Lead Technician, Inspection in West Chester, Ohio

Description:

The Lead Technician is a direct labor position reporting to a Process Execution Team Process Facilitator on the Manufacturing floor (Filling/Inspections), which supports Bulk/Diluent, Filling/Inspection, and Packaging operations. The position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment, performing in-process monitoring, line clearances, OEE data collection and completing batch record entries in accordance with cGMPs. In addition, the Lead Technician will perform setup of equipment, execute training for Technicians, direct product and environmental sampling activities and perform batch reconciliation and accountabilities per cGMPs.

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.

  • 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.

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

  • Perform inventory control and reconciliation activities, which may require use of SAP as needed within the team.

  • Work with various printing devices including printing mats, ink-jet, etc. Perform set-up of print and embossing blocks for lot information and expiration dating.

  • Certified OJT trainer for PET job skills and functions.

  • Working knowledge of automated and semi-automated inspection equipment.

  • Particulate inspection qualification for a pre-determined population of the team.

  • Schedule environmental sampling. Review environmental results and communicate trends to Process Execution Teams.

  • Flexibility in cross training between functions.

  • Follow batch and SOP instructions to perform in-process and finished product sampling.

  • Label and deliver samples to appropriate locations.

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

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

  • Assist technical staff as required with preventive maintenance procedures.

Minimum Requirements:

  • High school graduate, vocational school graduate or equivalent

  • Minimum two years experience in a pharmaceutical production 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 with corrective lenses (Vision screening completed on-site)

Preferred Background:

  • Working knowledge of Microsoft applications, SAP.

  • Experience working in a LEAN manufacturing environment

  • Knowledge of cGMPs and FDA policies/procedures

Internal/External Contacts & Customers:

  • PET staff

Required Competencies:

  • Basic knowledge of sterile room techniques, chemical handling and usage

  • Mechanical/technical aptitude

  • Ability to work effectively in a team environment

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