Chemical Laboratory Quality Assurance Technician
2 days ago
This is a crucial role that encompasses the entirety of quality control test activities. Responsibilities include assessing incoming materials, in-process materials, intermediate, API, and stability samples. The successful candidate will report to the Quality Manager and collaborate with colleagues to meet quality objectives.
Main Responsibilities
- Develop, validate, and transfer analytical methods, including cleaning method validation and troubleshooting.
- Provide analytical support throughout technology transfer and process validation phases, monitoring production and analytical results.
- Create and review laboratory documentation, such as method transfer and validation protocols, reports, SOPs, calibration procedures, and analytical test records.
- Conduct testing on raw material, intermediates, API, and materials associated with the reaction process and cleaning process according to approved procedures, including stability testing programs.
Requirements
- A Bachelor of Science in Chemistry with 2-3 years of quality control and analytical laboratory experience.
- HPLC experience is essential, while GC proficiency is desirable.
- A recognized LSS qualification (yellow belt, green belt, black belt) is highly desirable.
Key Skills and Competencies
- Ability to develop and adhere to self-directed standard work.
- Demonstrated skills in organizing and tracking data and documents.
- Capability to effectively apply knowledge, manage multiple activities simultaneously, and balance priorities to deliver objectives.
- Strong written and oral communication skills, as well as experience presenting to leadership teams.
- Must have strong technical/analytical skills and a demonstrated commitment to delivering results.
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