What are the responsibilities and job description for the QA Specialist position at Hydrogen Group?
🔹 Responsibilities:
* Review executed batch records and supporting documentation for completeness, accuracy, and compliance
* Support product release activities and ensure adherence to cGMP, GDP, and ALCOA principles
* Review deviations impacting batch quality and assist with CAPA activities
* Maintain quality documentation and support audit and inspection readiness
* Identify process improvement opportunities and contribute to quality initiatives
🔹 Qualifications:
* Bachelor's degree in a scientific discipline preferred (or equivalent experience)
* 2-4 years of QA experience in a GMP-regulated environment
* Experience reviewing batch records and supporting product release activities
* Working knowledge of FDA, EMA, and cGMP requirements
* Familiarity with quality systems including Deviations, CAPA, Change Control, and Document Control
* Strong attention to detail, organizational skills, and documentation practices
🔹 Ideal Candidate:
✔ Experience in pharmaceutical, biotechnology, manufacturing, or other regulated industries
✔ Strong understanding of quality systems and compliance requirements
✔ Ability to work independently and manage priorities effectively
✔ Commitment to quality, integrity, and continuous improvement
...
Salary : $65,000 - $75,000