Education & Qualifications:
- Bachelor’s degree or college diploma in a scientific discipline with 3 years related experience in a quality lab environment (pharmaceutical preferred)
- Strong understanding of GMP.
- Extensive knowledge of analytical tests.
- Some knowledge in protein analysis such as BCA, SDS-PAGE, and ELISA.
- Data Review, statistics and trending report preparation with knowledge of MS Word, Excel and Outlook.
- Knowledge of compendial test requirements, US and Europe Pharmacopea.
- Candidate must be self-motivated, highly organized and able to work in the fast paced environment.
- Ability to learn the QC test procedures and protocols quickly.
Duties & Responsibilities:
- Review in-process, final product, cleaning validation/verification test results for completeness and accuracy. Ensure all results conform to specifications, GMP, compendial and regulatory requirements.
- Review Instrument calibration and preventive maintenance documents to ensure all data conform to work orders, protocols and SOPs.
- Verify the entries in the sample log book.
- Periodically review the instrument logbooks for completeness.
- Participate in preparing trending reports for final test results and test controls.
- Participate in verifying USP and EP test method to ensure compliance with current revisions.
- Review test summary sheets to ensure that the test results and associated reference numbers have been transcribed correctly.
- Follow established templates for preparing CofAs for Stability and Final products.
- Consult with Analysts to ensure that the all necessary corrections are made in a timely manner.
- Report to the supervisor immediately any deviations from QC procedures, or other discrepancies that may arise during the review of documents.
- Review completed log books and test result books. Work with QA to archive them properly.
- Perform other document reviews after training to support activities in the QC Chemistry Laboratory.
- Ensure documentations are accurate and up to date.
- Overtime will be required to meet business needs.