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Production Tech II(P108163)

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Production Tech II(P108163)

  • 2021-23648
  • Portland, Maine, United States

The production technician is responsible for producing or supporting production of instruments or reagents products in compliance with established GMP procedures and ensuring products are of consistent high quality. Perform production activities and or provide support to production operation, perform ERP system transactions, and support training of personnel assigned to Production Department.   This position would be a combination of shipping/receiving and support in manufacturing.  That would include washing dishes, making buffers and cleaning

Responsibilities

Performs moderately complex, directed lab experiments.

  • Provides weekly and monthly reports for manufacturing processes as assigned by supervisor.
  • Maintains accurate inventory of all printed material.
  • Recommends and facilitates in-depth changes to interdepartmental written procedures.
  • Supports laboratory testing by operating laboratory instruments, ordering reagents, and performing good laboratory practices and procedures.
  • Performs complex instrument operation and maintenance, etc.

Prepares for production by reviewing production schedule; assembling and weighing materials and suppliesProduces requirements by operating and monitoring equipment; observing varying conditions; adjusting equipment controls; calculating concentrations, dilutions, and yields; adhering to aseptic filtering and filing procedures or and/or system test on product subassemblies or final instruments.

  • Maintains safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment.
  • May perform simple to moderately complex lab experiments.
  • Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
  • Documents production by completing forms, reports, logs, and records of equipment and batches.
  • Provides testing support in the lab as needed.
  • May provide basic assistance/training to new employees and/or new processes.
  • May perform simple instrument operation and maintenance.
  • Other duties as assigned. Daily Shipping and receiving duties.

Vialing of product, washing dishes, and making buffers and media for manufacturing.

Qualifications

High school diploma, GED, or equivalent.  Associate degree preferred.

  • College level courses and/or specialized training in the assigned technical discipline preferred.
  • 3-5 years related experience or equivalent combination of education and experience.
  • Working knowledge of quality systems, cGMP, and precedents, policies, and procedures in the specialty area.
  • Ability to operate lab/test equipment and to apply common sense to carry out semi-complex written or oral instructions.
  • Strong math, problem solving and computer skills.
  • Transaction in SAP a plus.
  • Experience operating manual, semi-auto and automatic production machinery, preferred.
  • Utilize intermediate technical skills to troubleshoot equipment.
  • Ability to prioritize work.
  • Accurate and detail-oriented.
  • Team player/ flexible/ attentive to detail and quality minded.
  • Ability to work a flexible schedule, with overtime and weekends as needed.
  • Must be able to train others.

2 years experience in shipping and receiving is prefered. 

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