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QA Technician

  Irwindale, CA,  United States |  Full time

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Posting Date :  2022-01-03

Job Identification :  10942

Department  :  Quality Assurance

QA Technician will sample, inspect and release raw materials, finished product, components, labeling materials. The QA technician coordinates with production department to ensure proper support is provided. Also, coordinates with the Quality Control department for sampling and testing to ensure materials are released in a timely manner. Supports packaging and powder lines for line releases. All work is performed maintaining compliance with cGMPs and following standard operating procedures. QA technicians will perform initial review of batch records, line clearance and line release, product hold and product disposition. Oversee sample retention program.

Key Responsibilities:

  • Coordinates sampling of incoming raw materials and provides samples to QC labs for testing and release.
  • Coordinates sampling and performs testing of incoming components (i.e. vials, stoppers, seals); this includes coordinating sending samples to contract labs as needed.
  • Inspects and releases labels and packaging materials; this includes performing counts of labels using the label counter machine.
  • The position requires the individual to gown appropriately to the respective production rooms including aseptic gowning.
  • Perform monitoring of non-sterile powder filling operations which includes line clearance and release.
  • The job responsibilities require the ability to lift, push, pull and carry up to 50 pounds; it requires a combination of walking around the facility along with sedentary work.
  • Document work in master production records, logbooks, data sheets, as applicable.
  • Perform status change in QAD for release of raw materials, components and labels.
  • Participate and write environmental notifications and deviation investigations, as applicable.
  • Prepares paperwork and labels for samples and provides respective specification sheets with samples submitted to QC lab or Microbiology for testing.
  • Prepare and revise standard operating procedures.
  • Ensure all work is carried out in compliance with Good Manufacturing Practices (cGMP) and company Safety policies.
  • Perform Line clearance and Line release for manufacturing.
  • Perform Product Hold/ Product disposition.
  • Train personnel for tasks mentioned above.
  • Oversees sample retention program.
  • Prepares CofA.
  • Modify procedures as needed.

Requirements:

Essential:

  • Minimum of 1-3 years experience in Manufacturing environment
  • Familiarity with cGMPs
  • Minimum High School Diploma
  • Good aseptic techniques
  • Good documentation skills 
  • Good computer skills
  • Strong collaboration skills with other departments (i.e. production, quality control, validtions)
  • Must be able to manage competing priorities

Desirable:

  • Pharmaceutical manufacturing experience
  • Bachelor’s degree in Sciences
  • Aseptic gowning qualification
  • Ability to communicate effectively defending quality initiatives and compliance

 

 

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