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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

Receiving: All materials as per receiving procedure. All discrepancies from the receiving procedure need to be brought to a supervisor’s attention. The areas should be kept neat and clean, boxes are to be broken down and disposed of properly.

Receiving of Samples & Raw Materials: Receive all incoming raw materials per receiving procedure, in a timely manner. Take quarantine samples and complete all appropriate paperwork. Notify Q.C. of incoming samples. Receive samples (such as pleural fluids and other raw materials) and deliver to Q.C. Department to screen as appropriate. File paperwork accordingly.

Shipping: All shipments should be shipped according to the customer order form. Ship all orders accurately, on time at the proper temperature. Supplies should be inventoried & ordered when needed to avoid shortages, shipping area kept neat and clean

Vialing: Vial orders according to vialing procedure, completing prior to due date. Check with appropriate personnel to follow the progress of late material. Keep vialing room neat and clean. Disinfect counter tops when needed. Vialing supplies should be inventoried regularly and ordered when needed to avoid shortages.

Inventory: Enter inventory transfers into the folder. Help implement and perform cycle counting and reconciliation of inventory. Bring discrepancies to a supervisor.  Assist in annual inventory count and reconciliation. Help reconcile physical count, file and computer inventory levels. Keep inventory of supplies in stockroom and help purchasing minimize inventory outages.

Clean/disinfect bench tops and equipment as required. Autoclave all glassware and tubing. Stock all cabinets, etc.

Preparation of cell culture and bacterial fermentation Medias and buffers for MFG and R&D.

Water system maintenance. Assist with celligen set up and take down. Compressed gas maintenance, maintenance of bioreactor gases and CO2 incubators.

Assist with IQ, OQ, PQ: Test incoming equipment and complete paperwork for acceptance.

Assist in coordination of equipment repair, calibration and maintenance.

Initiate and make changes to SOP documents when necessary.

Cleaning of Lab ware/equipment.

Harvest and feed cell factories.  Concentrate harvested media.

Chemical inventory maintenance.

Other: Other QA/QC or maintenance duties as necessary. Examples: Fill out temp logs, generation of paperwork and light maintenance.

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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