Quality Assurance Associate
The Quality Assurance Associate at Confidential Client plays a critical role in ensuring compliance with regulatory standards by reviewing and approving batch records and technical documentation for animal health products. This position provides on-the-floor quality support, assists with audits, manages deviation investigations, and supports continuous improvement initiatives to facilitate the release of safe and effective biological products.
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.
Summary
Confidential Client is seeking a Quality Assurance Associate to provide production-facing QA support for batch record review, technical documentation, deviations, and SAP release activities. This role helps ensure product compliance with USDA, FDA and EU regulations and supports audits, investigations, and continuous improvement efforts.
Responsibilities
- Perform detailed review and approval of batch records and associated technical documentation for routine production, validation, and change-control activities to ensure regulatory compliance (USDA, FDA, EU).
- Provide real-time, on-the-floor quality support during batch reviews, process audits, and production activities.
- Support deviation management by identifying non-conformances, participating in root-cause analysis, and co-authoring investigation reports.
- Assist with preparation and responses for internal and external inspection audits.
- Track and report continuous improvement goals in collaboration with the Process Team.
- Execute usage decisions and release transactions in SAP to manage product movement and final disposition.
Who You Are / 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).
- 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.
- Strong written and verbal communication skills; able to support investigations and audit responses.
Preferred Qualifications (Competitive Edge)
- Direct prior experience in QA batch record review and release.
- In-depth knowledge of USDA and EU regulatory requirements for biological products.
- Familiarity with electronic quality management systems (deviations, change control, CAPA).
- Strong technical writing skills for investigation and audit documentation.
Estimated Compensation
- Estimated salary: $64,101 per year (as listed in source). Actual pay may vary based on experience, location, and role level.
What You’ll Gain
- Hands-on QA experience supporting biologics/production processes and regulatory compliance.
- Exposure to SAP and electronic QMS tools.
- Opportunity to support audits, continuous improvement projects, and cross-functional teams in a Scientific & QA environment.
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.
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