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Astrix Inc

QA Associate - cGMP

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Job Description

Our client focuses on therapies for widespread, chronic diseases, such as central nervous system disorders, addiction, diabetes and autoimmune disorders, where we feel we can make the greatest impact.
Position:
Quality Assurance Associate Pay Rate:
$24 - $26/ hour
Location:
Wilmington, OH 45177
Schedule :
Monday-Friday 1 st shift
Type :
Contract to hire Position Summary The position will perform general QA activities using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations. Works on problems of a diverse scope where problem solving is required. Receives general oversight and guidance on approaches to complete project related tasks. The ideal candidate will apply skilled problem-solving abilities under general supervision to ensure continuous adherence to current Good Manufacturing Practices (cGMP).
Key Responsibilities Manufacturing & Shop-Floor Support:
Conduct on-the-floor batch record reviews, visual equipment inspections, equipment releases, status tagging, work order reviews, and room/utility checklist verifications.
Compliance & Monitoring:
Monitor cGMP compliance throughout the facility and product lifecycle; partner with plant personnel to enforce compliance standards.
Investigation & Corrective Actions:
Follow up on preventive and corrective actions (CAPA) related to deviations, laboratory investigations, and environmental excursions.
Documentation:
Review logbooks, facility records, and production documents for accuracy and completeness.
Operational Flexibility:
Provide backup coverage for other Quality Assurance roles as needed.
Qualifications & Requirements Education & Experience:
Bachelor's degree in a scientific discipline (or equivalent experience). Relevant pharmaceutical industry experience may be substituted for a degree. Minimum of 1 year of Quality Assurance experience in the pharmaceutical industry preferred.
Technical Skills & Knowledge:
Working knowledge of US Drug Product cGMP regulations and industry guidelines. Experience with quality systems administration in drug product manufacturing and quality control environments. Strong written, verbal communication, and computer skills.
Physical & On-Site Requirements:
Ability to wear aseptic gowning and Powered Air-Purifying Respirator (PAPR) equipment for up to 4 consecutive hours. Must successfully pass required health assessments prior to the start date. Must pass all post-training assessments and certifications. Key Competencies High attention to detail, organization, and problem-solving initiative. Ability to prioritize and manage multiple open issues simultaneously in a fast-paced environment. Strong work ethic, dependability, and a collaborative, team-oriented mindset. INDBH #LI-MG1