Vacancy expired!
- Review and approve all tests results, including raw data and electronic data generated in support of testing of raw materials, in-process, finished product and/or stability samples including all tests according to the in-house monographs and USP in a regulated laboratory environment.
- Review all validation and method optimization reports.
- Review all laboratory notebooks for correctness of raw data and verify all reagents, standards and equipment used are within the acceptable range.
- Ensure chemists follow all SOPs and cGMP regulations and use the correct method or procedure for each product.
- Ensure all testing/analysis is conducted according to approved test methods, standard operating procedures and/or associated documents and meets the product specific requirements.
- Ensure notebooks are reviewed in a timely manner, in accordance with SOPs. Sign off on all analytical test results and reports.
- Support QC and QA managements during regulatory, customer, corporate, and internal audits.
- Work with analysts for document corrections and provide guidance accordingly. Guide analysts on laboratory notebook documentation requirements.
- Analyze and interpret results in written and oral format.
- Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
- Performs other duties and projects as assigned by management.
- Health insurance
- Casual Dress code
- 401k match
Vacancy expired!