Quality Assurance Associate - 242795 Job at Medix™, Rockford, IL

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  • Medix™
  • Rockford, IL

Job Description

Quality Assurance Associate (Direct Hire)

Location: South Beloit, IL

Shift: M-F, business hours

Pay: $45,000 annually

Qualifications:

  • Preferred: 3–5 years of QA experience in a pharmaceutical or laboratory setting
  • Strong working knowledge of cGMP regulations
  • Exceptional organizational skills and attention to detail
  • Proficiency in Microsoft Word and Excel
  • Solid technical writing capabilities (writing sample may be requested)
  • Ability to work both independently and collaboratively within a team

Responsibilities:

  • Provide analytical and technical support for product development, including formulation reviews and protocol approvals
  • Review and interpret analytical data, including stability reports and trends
  • Participate in the preparation and review of CMC sections for abbreviated new drug applications
  • Oversee document control processes, including the activation and distribution of SOPs, specifications, and protocol
  • Conduct lab audits and ensure compliance with QA requirements
  • Maintain and issue batch records and perform final batch reviews, including release and pedigree documentation
  • Manage documentation for preventive maintenance programs
  • Utilize and support various quality and lab software systems, including calibration, documentation, and temperature monitoring tools
  • Draft and manage investigation reports and incident documentation
  • Provide general technical support across quality assurance functions as needed

Job Tags

Shift work,

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