Quality Assurance Technician

2 weeks ago


Toledo, Toledo, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly Science, Engineering, Technology & Telecom is in search of a Quality Assurance Technician II.

  • Location: West Chester, OH
  • Duration: 6 months
  • Rate: $24-26/hr.

Position Overview: The Quality Assurance Technician II (Temporary) is responsible for independently executing tasks related to environmental oversight to meet the compliance standards of a sterile production facility. This role involves operating equipment in various classified and non-classified settings, including environments up to a Class 100 aseptic area and laboratory environments.

Key Responsibilities:

  • Document activities, actions, and outcomes meticulously. Adhere to proper documentation protocols during job functions. Review Standard Operating Procedures (SOPs) and relevant technical documentation.
  • Maintain comprehensive and accurate records, such as laboratory notebooks, quality documentation, and sample receipts.
  • Complete necessary training programs.
  • Conduct visual inspections as required.
  • Utilize MODA for sample collection and analysis.
  • Provide guidance on SOPs, control documents, and other operational instructions. Coordinate with support teams.
  • Ensure compliance with cGMP standards during laboratory tasks performed by others.
  • Conduct regular reviews of SOPs and work instructions.
  • Perform routine sampling and associated data entry tasks.
  • Wear appropriate gowning, sterile garments, and Personal Protective Equipment (PPE) as dictated by specific tasks.
  • Interpret diagrams, drawings, and schematics accurately.
  • Propose and initiate actions to maintain compliance of areas and equipment.
  • Offer 24/7 on-call support as needed.
  • Provide timely feedback regarding service and quality concerns.
  • This role may require shift work, including weekends and occasional extended hours with potential short-notice schedule changes.

Minimum Qualifications:

  • Proficient in understanding, reading, writing, and communicating in English.
  • Strong attention to detail is essential.
  • Ability to maintain accurate records and perform mathematical calculations.

Preferred Qualifications:

  • High school diploma, vocational school completion, or equivalent experience.
  • Two years of experience in a pharmaceutical production setting.
  • Familiarity with MODA, Microsoft applications, SAP, KRONOS, and Trackwise.
  • Experience in a LEAN manufacturing environment.
  • Understanding of cGMP regulations and FDA policies/procedures.


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