About Careertakes

👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.

Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.

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What You’ll Do

Confidential Client is seeking a Quality Associate to provide production-side quality assurance and support for QA Release and Process teams. You will review and approve batch records and technical documentation, provide on-the-floor quality guidance, and help ensure products meet regulatory standards.

• Perform detailed review and approval of batch records and associated technical documentation (routine production, validation, change control) to ensure compliance with USDA, FDA, and EU regulations
• Provide real-time, on-the-floor support for batch reviews, process audits, and quality-related questions for production personnel and Process Team members
• Support deviation management: identify non-conformances, help determine root cause, and participate in investigation report writing
• Assist with internal and external inspections and audits by preparing documentation and responding to requests
• Execute usage decisions and release transactions in SAP to manage product movement, disposition, and final release
• Support continuous improvement initiatives and track progress on site-level quality goals

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Role & Compensation

• Location: West Fort Dodge, IA — On-site work environment
• Employment type: Full time, Permanent
• Salary: $65,966 per year (estimated)
• Travel: None
• Level: Entry (P1) through Senior (P2) — this posting is for Associate level responsibilities; responsibilities and expectations vary by level

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Minimum Qualifications

• Bachelor’s degree in a scientific discipline OR High School Diploma/GED with equivalent relevant experience
• 1–2 years’ experience in a GMP-regulated environment (pharmaceuticals, biologics, or similar)
• Demonstrated experience reviewing GMP-regulated documents such as batch records, SOPs, and quality investigations
• Strong attention to detail and proficiency with Microsoft Office; experience with SAP and Veeva preferred

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Preferred Qualifications (competitive edge)

• Direct experience in QA roles reviewing and releasing batch records
• In-depth knowledge of USDA and EU regulatory requirements for biological products
• Experience with electronic quality management systems (deviations, change control, CAPA)
• Strong technical writing skills for investigation reports and documentation

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Working Conditions & Additional Info

• On-site position in West Fort Dodge, IA — regular presence at the manufacturing site is required
• Day-to-day tools/systems: SAP for release transactions; electronic QMS platforms (e.g., Veeva) may be used for deviations/change control/CAPA
• Confidential Client values diversity and inclusion and supports reasonable accommodations during recruitment and employment

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Equal Opportunity & Hiring Transparency

Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.

If you have questions about how your data is used, please contact us directly.