Quality Technical Specialist
New
United StatesFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- Minimum of 3 years of experience
- Required Skills
- Microsoft Office
Requirements
- Bachelor’s degree in Biology, Biotechnology, Bioengineering, Chemistry, Chemical Engineering, or a related scientific field.
- Minimum of 3 years of experience in technical services, quality, engineering, or sales within the chemical or pharmaceutical industry.
- Strong understanding of pharmaceutical and biopharmaceutical development, manufacturing processes, and regulatory frameworks (cGMP, FDA, ICH, WHO).
- Experience in quality assurance, process engineering, or laboratory/manufacturing environments is highly desirable.
- Strong analytical and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.
- Excellent written and verbal communication skills, with strong attention to detail and customer focus.
- Proficiency in Microsoft Office Suite and ability to quickly learn new systems and technical tools.
- Preferred: project management experience and hands-on laboratory or manufacturing exposure.
Responsibilities
- Manage and support Customer Quality Agreements, including drafting, reviewing, negotiating, and maintaining compliance in collaboration with legal and internal stakeholders.
- Respond to customer technical and quality inquiries related to pharmaceutical and laboratory products, ensuring accurate and timely communication.
- Research and interpret technical documentation, product specifications, and regulatory standards (cGMP, FDA, ICH, WHO) to support customer and internal needs.
- Maintain and update quality documentation, databases, and systems to ensure accuracy, traceability, and compliance.
- Collaborate cross-functionally with Quality Assurance, Sales, Marketing, and R&D teams to improve quality processes and customer support workflows.
- Participate in continuous improvement initiatives, including lean process optimization and efficiency enhancements for quality agreement management.
- Support cross-functional customer programs, including data collection, reporting, project coordination, and stakeholder engagement.
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