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

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