Spec 3, Quality Assurance
920 19th Street East Columbus, NE 68601 US
Job Description
Pay: $31/hr
Schedule: Onsite, full-time
Contract Type: Contract (potential for extension or hire)
Why You’ll Want This Role
Join a leading manufacturer focused on product safety, process improvement, and regulatory compliance. You’ll play a key role in investigating quality issues, supporting continuous improvement, and ensuring adherence to industry standards such as GMP and ISO. This position offers valuable experience in a fast-paced, technical environment with long-term growth potential.
Key Responsibilities
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Investigate and respond to customer complaints promptly and accurately.
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Determine investigation paths and assess issues against established quality criteria.
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Conduct thorough root cause analyses and develop corrective and preventive actions (CAPA).
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Review batch records, change control documentation, and quality trends.
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Write clear, technical reports summarizing findings and outcomes.
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Collaborate with other Quality Specialists to maintain consistent investigation timelines.
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Support compliance with quality systems, SOPs, and applicable regulations.
Qualifications
Required:
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High School Diploma or GED
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1–3 years of experience in a GMP-regulated environment
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Strong skills in:
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Statistical and analytical problem solving
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Technical writing and communication
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Quality systems knowledge (GMP, ISO)
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Preferred:
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Bachelor’s degree in Engineering, Science, or related field
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1–3 years of experience using root cause investigation tools
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Previous work in pharmaceutical or medical device manufacturing
Top Skills for Success
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Root cause investigation (5 Whys, Fishbone, CAPA)
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Data analysis and documentation accuracy
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Clear written communication
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Detail-oriented and compliance-driven mindset
Why Candidates Apply
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Competitive pay rate of $31/hr
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Opportunity to build regulated industry experience
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Hands-on, technical quality role with process ownership
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Stable onsite work environment
Call to Action
If you’re ready to put your analytical and problem-solving skills to work in a quality-driven manufacturing environment, apply today to join the client’s company in Columbus, NE!