Hsv - Manufacturing Operator - 2Nd Shift 4/10'S

Job Summary:

Performs functions relating to the manufacturing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Learns to apply skills and knowledge to recognize issues and to increase efficiency, throughput, and quality. Learns, understands, and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, may participate in the debrief to understand the reasons why and what needs to be corrected moving forward. Assists in troubleshooting process issues. Responsible for the safe and efficient execution of job duties.

Job Responsibilities:

• • Operates pharmaceutical manufacturing equipment such as processing tanks, pumps, mixers and tank farm applications.
  • Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify that product can be released for distribution.
  • Learns and performs master cleans/surface cleans of manufacturing equipment and facilities according to established SOPs.
  • Learns to do basic set-ups of manufacturing equipment train.
  • Requires oversight and double-checking; is typically paired with a Qualified Liquids Manufacturing Operator II or higher.
  • Learns sampling techniques at end of batch processing.
  • Learns, understands, and runs processes to meet the assigned schedule; when this is not achieved, may participate in the debrief to understand the reasons why and what needs to be corrected moving forward.
  • Learns & performs: Weighing and Liquids Manufacturing
  • Develops and applies basic knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position. Focused on a limited range of activities.
  • Learns and completes documentation associated with manufacturing processes (e.g., logbooks) with detail and accuracy.
  • Learns to troubleshoot process issues with guidance.
  • Learns to identify deviations in processes and execute the established path forward; refers deviations from standard procedure to the supervisor.
  • May participate in Continuous Improvement projects.
  • Learns and sustains the 6S process where implemented
  • Carries out processing manufacturing activities safely, as required, on a daily basis.
  • Follows all safety and compliance procedures and participates in required training.
  • Adheres to all cGMP compliance/regulatory mandates and quality requirements.
  • Participates in safety teams, start-up discussions, incident debrief, etc.
  • Ensures compliance with SOPs, Policies and Procedures as required by TriRx Safety policies and regulatory agencies

  Conforms to all training requirements, including company required and machine-specific training.

  Learns the responsibilities of being a team member. Contributes to team and project success by sharing novel insights. Collaborates typically within own cross-functional work unit. Maintains active communication with customers to facilitate continuous improvement. Other duties as assigned.

Qualifications:

• High School Diploma or GED required.
• Good PC Skills, including use of e-mail, attaching documents to e-mail. Previous experience using electronic databases and on-line system applications.
• Demonstrated ability to work safely in a production environment required.
• Demonstrated ability to read/interpret/follow instructions regarding workplace documentation, such as SOP’s, Operator Manuals, Work Instructions, etc.
• Demonstrated technical ability as measured by good troubleshooting skills.
• Must be able to demonstrate a good mathematical aptitude in addition, subtraction, multiplication, division, & metric system.
• Experience in a government regulated, Good Manufacturing Practices (GMP) or standard operating procedures (SOP) environment preferred.
• Must be willing to work overtime as required, based on production demands.