This position is responsible for handling cGMP related issues, and is well-versed with investigation system, internal and external audits and in quality oversight of contract manufacturers. A Quality Analyst is responsible for timely, efficient and effective functioning of the Quality Investigations; and performs in compliance with current regulatory and company expectations.
- Responsible to perform analytical testing of raw materials, in-process and finished pharmaceutical products
- Read, understand and interpret analytical methodology
- Responsible to maintain, calibrate and inspect all testing equipment.
- Responsible to maintain the cleanliness of the area and take care of waste management
- Ensure compliance with cGMP and cGLP requirements
- Maintain accurate records of work performed
- Responsible to pull customer samples, retain samples and any other samples requested by supervisor or customer
- Ensure that safety, health and environmental policies are being followed
- Coordinate with the team to ensure all deadlines are met
Eligibility: Bachelor’s in Chemistry or related science, analytical laboratory experience (preferred), strong background in Quality Assurance Management, cGMP, GCP, ISO, GLP, QSR regulations and close out deviations. Experience with Track Wise preferred.