Job Details

West Chester, OH

Contract Duration: 6-36 months

Rate: Negotiable

Salary: NA, $1.00

Responsibilities:

• Excellent employment opportunity for a Manual Packaging Operator in the West Chester, Ohio
• 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 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. 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.
• 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.

• High School Diploma
• One 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.
• Prior production experience required
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures
• Internal/External Contacts & Customers: PET staff
• Schedule: 4-10 Day Shift (4 days a week; 10 hour shifts)