Quality Engineer

1 day ago

st louis, United States Indotronix International Corporation Full time

Job Position: Quality Engineer

Location: St. Louis MO 63147

Duration: 6+ months


Job Description:

The Quality Engineer– Stability performs essential duties in ensuring the Stability Program operates effectively and complies with US and International pharmaceutical manufacturing regulations/guidance documents. The responsibility includes packaging, storage, and delivery of stability material promptly to avoid undue burden on the testing laboratories, updating department Work Instructions or site Quality System Procedures, and developing solutions to routine technical problems of limited scope to improve department efficiencies.

Essential functions:

  • Manages and maintains stability samples under ICH, FDA, DEA, and cGMP regulations.
  • Pulls and delivers stability samples at testing intervals.
  • Package stability samples per study requirements.
  • Maintains controlled substance inventory in compliance with applicable DEA regulations.
  • Works with the LIMS team to ensure the stability module of the LIMS system is maintained and functional.
  • Ensure stability studies are entered into LIMS accurately and timely.
  • Responsible for packaging, labeling, and storage of stability samples.

Department specific/non-essential functions:

  • Shares responsibility for Stability Packaging functions and sample pulls as needed.

Minimum requirements:

  • Education: Some technical, community college, or college credits.
  • Experience: Minimum of 1-year related experience in Quality programs.
  • Some knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements.

Preferred Skills/Qualifications:

  • Excellent communication skills.
  • Ability to work in and promote a team environment.
  • Understanding and application of principles, concepts, practices, and standards within the discipline.
  • Knowledge of stability chambers and laboratory equipment.
  • Ability to read and interpret graphs.
  • Ability to lead and influence people.
  • Understanding of basic statistical principles.
  • Other Skills: Knowledge of ELN, LIMS, Excel, and Minitab.

Competencies:

  • Dealing with Ambiguity, Approachability, Decision Quality, Functional/Technical Skills, and Integrity and Trust.
  • Customer Focus.

Relationships with others:

  • Works frequently with internal customers including QC, QA, Validation, and APIDs.

Working conditions:

  • 50% Laboratory exposure to plant products, solvents, and reagents, some of which are hazardous or potent compounds.
  • 50% Office environment includes sitting for long periods and computer use.

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