Location: Durham,NC, USA
Job Description: Working hours will be Hours: Sunday - Friday 11pm-7:30am, Overtime every other weekend required, Candidates must be ok with Saturdays and Sundays OT The Packaging Technician position is responsible for the operation of high-speed equipment used in the production and packaging of BacT/ALERT bottles and/or preparing and formulating the liquid reagents that fill the finished BacT/ALERT bottle in a cGMP compliant manner. The position may perform or assist in the setup, inspection, preventive maintenance, troubleshooting and cleaning of equipment used throughout the BacT/ALERT Manufacturing and Packaging processes. Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated tasks. AQL inspections, reworks and Material reconciliation that goes along with the batch. Main Job Duties: 1. Production a. Manufacturing & Packaging: Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces. b. Formulation: chemical weighing and reagent formulation c. Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs. 2. Quality a. Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner. b. Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations. c. Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of products. d. ssist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns. e. Maintain all work areas in a well-organized, clean, and tidy manner at all times in compliance with cGMP requirements. 3. Safety a. Comply with all safety policies and procedures at all times. b. ppropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties. 4. Other Duties a. Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making. b. ssist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state. c. Perform computer applications. d. Perform other duties as assigned by Management. Education & Experience: 1. Minimum of High School Diploma or Equivalent. 2. Minimum of 0-1 years in a regulated production/operations environment. 3. Certification in Bio works Program preferred. 4. Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred. Physical & Other Requirements: Ability to Lift 25-50lbs frequently and throughout shift. Ability to push and pull 50-100lbs frequently and throughout shift. Performs all job functions and responsibilities in a safe and responsible manner. Ability to regularly climb stairs to perform work. Ability to operate motorized pallet jacks. May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials. May be exposed to strong odors incurred during media production or other operations. Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat. Make-up and jewelry are prohibited in certain areas of Manufacturing. Ability to maintain reliable and punctual attendance. Ability to work overtime as required to support a 24/7 production operation.