Medix™
Quality Assurance Associate (Direct Hire)
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
Seniority level Associate
Employment type Full-time
Job function Quality Assurance and Manufacturing
Industries Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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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
Seniority level Associate
Employment type Full-time
Job function Quality Assurance and Manufacturing
Industries Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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