QA Release & Validation Specialist in United States at Jobgether
Explore Related Opportunities
Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a QA Release & Validation Specialist based in the United States.
This role sits at the center of quality assurance within a highly regulated life sciences manufacturing environment, ensuring that every product batch and validation activity meets the highest standards of safety, accuracy, and compliance. You will be responsible for reviewing and approving critical documentation supporting product release, testing, and validation processes that directly impact patient-facing outcomes. Working closely with production, QC, and validation teams, you will help safeguard data integrity and regulatory adherence across operations. The position requires strong attention to detail, scientific rigor, and confidence working within GMP frameworks. It offers the opportunity to contribute to life-changing innovations in a mission-driven scientific organization. This is an on-site role with exposure to complex biomanufacturing and cross-functional collaboration. You will play a key role in ensuring that only fully compliant and accurately validated products move forward in the development lifecycle.
In this role, you will be responsible for ensuring the integrity, compliance, and readiness of critical quality documentation that supports product release and validation activities.
- Review and approve executed batch records, QC test results, and product disposition documentation to ensure accuracy, completeness, and regulatory compliance.
- Evaluate validation documentation for equipment, processes, computer systems, and analytical methods against approved protocols and GMP requirements.
- Ensure all deviations are properly documented, investigated, and resolved prior to product release decisions.
- Serve as a quality assurance reference point for release and validation activities, escalating and resolving non-conformances when required.
- Support compliance with applicable regulatory standards including internal SOPs, FDA regulations, and global quality guidelines.
- Collaborate with cross-functional teams to maintain documentation control and support continuous quality improvement initiatives.
The ideal candidate brings hands-on experience in regulated environments and a strong foundation in quality systems, documentation review, and compliance standards.
- 1+ year of experience in a Quality Assurance, auditing, or compliance-related role.
- Experience working in a GMP-regulated or similarly controlled manufacturing environment.
- Bachelor’s degree in life sciences or a related scientific field preferred, or equivalent practical experience.
- Strong understanding of documentation control, batch record review, and validation principles.
- Familiarity with regulatory frameworks such as FDA CFR requirements and/or EU GMP standards is a plus.
- High attention to detail with strong analytical and problem-solving skills.
- Ability to work independently while managing multiple priorities in a structured, deadline-driven environment.
- Strong communication skills and confidence collaborating with technical and operational teams.
- Competitive salary range aligned with experience and qualifications
- Annual bonus and incentive compensation eligibility
- Comprehensive medical, dental, and vision insurance
- 401(k) retirement plan with employer contributions
- Paid time off and flexible leave policies
- On-site role with access to structured training and continuous improvement systems
- Opportunity to contribute to life-impacting scientific and biotechnology innovations
- Inclusive and collaborative work environment focused on quality and excellence.