About this role
The Specialist Quality Control will be responsible for ensuring product quality and regulatory compliance within a pharmaceutical manufacturing environment. This role focuses on method validation, method transfer, and method qualification to support robust analytical processes.
Day-to-day activities include planning and executing method validation studies, coordinating method transfers between sites, and qualifying analytical methods to meet industry standards. Project management skills are essential for overseeing timelines and deliverables across multiple quality control initiatives.
The specialist collaborates with cross-functional teams including R&D, manufacturing, and regulatory affairs to ensure seamless integration of quality systems. Bilingual communication in English and Spanish is required to effectively interact with diverse teams and stakeholders.
This position offers the opportunity to contribute to critical pharmaceutical quality assurance processes and develop expertise in analytical methodology within a leading industry setting. The role supports career growth through exposure to complex validation projects and regulatory requirements.
Requirements
- Doctorate or Master's degree plus 2 years of directly related experience, or Bachelor's degree plus 4 years of directly related experience
- Scientific background in Biochemistry, Chemistry, or Microbiology at the Bachelor's degree level
- Good communication skills
- Ability to work effectively with multi-functional teams
- Bilingual proficiency in English and Spanish
Responsibilities
- Perform method validation to ensure analytical procedures meet regulatory and internal standards
- Lead method transfer activities between laboratories or manufacturing sites to maintain consistency
- Conduct method qualification to confirm suitability for routine testing
- Manage quality control projects, coordinating timelines, resources, and deliverables
- Collaborate with multi-functional teams to address quality issues and drive continuous improvement
- Prepare and review technical documentation related to validation and qualification activities
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