Quality Engineer

Location: Waltham, MA
Department: Azzur Cleanrooms On Demand Boston LLC

Job Description

Essential Functions:

  1. Describe the overall purpose and objectives of the position, the results the employee is expected to accomplish and the degree of freedom to act
  2. Essential functions are the primary reason the position exists, how this job affects other positions and the organization
  3. Essential job functions focus on the results or outcome of a function, not solely on the way it customarily is performed
  4. Provide percentage of time spent on each task or group of similar tasks
Job content should be measurable, attainable & goal oriented; tasks, duties and responsibilities of the position that are most important to get the job done.

Insure appropriate Quality Management of material management shipping and receiving in accordance with company policies and procedures. Examples of these duties include:

  1. Provide quality oversight of materials management, shipping and receiving, inventory control assignments and various client required assignments. These duties insure client and Internal COD operations are performed in compliance with relevant site and client procedures and pertinent regulatory requirements. Typical duties include oversight and review of:
    1. Shipments and documented according to site and client procedures.
    2. Client material shipments in compliance with temperature control and chain af custody requirements.
Review of internal GMP operations to insure compliance with relevant procedures and regulations.

Support Client Quality Management. Examples of these duties include:

Support quality systems that document the cause and effect of events that deviate from normal operations. Examples are material handling excursions, controlled area environmental excursions and facility operation service interruptions.

Provide onsite client support during clean room operations to insure client business needs are executed as planned. This support can include off-hour support (weekday evenings and weekends).

  1. Review and approve client raw material transactions needed to support manufacturing operations.
  2. Provide training to clients to insure compliance with the COD Quality Management System.
  3. Write and execute documents to support the commissioning and qualification of client equipment or process operations as agreed to in client Statements of Work.
Provide onsite customer support during clean room operations to insure client business needs are executed as planned. This support can include off-hour support (weekday evenings and weekends).
  1. Review and approve client raw material transactions needed to support manufacturing operations.
  2. Review and approve client raw or product storage material transactions requiring controlled temperature storage (e.g., 2-8°C, -20°C, -80°C, Cryogenic storage) to insure client temperature sensitive materials are properly maintained.
  3. Maintain high purity gas utilities to insure client availability to support operations.





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