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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