Working with some supervision, applies established knowledge of laboratory techniques such as HPLC, dissolution, moisture by KF, GC, TLC, and others to perform pharmaceutical product stability testing. Candidate will be responsible for understanding and performing routine analytical testing for stability samples, evaluating and documenting results in a timely manner. Understands and follows all SOPs and written test procedures. Performs testing within established standard test times and maintains quality and productivity at acceptable levels as communicated by the supervisor. Candidate will execute troubleshooting of instrumentation and will be expected to maintain laboratory equipment in good working condition. Candidate will perform laboratory investigation steps with appropriate approvals and with guidance from supervisor. Candidate will understand the investigation process and begin to assist in preparation of laboratory investigation documents. Keeps supervisor fully informed of all results and project status on a daily basis and reports critical information in a timely manner. Should have some ability to multi-task. Will be expected to perform other tasks as assigned by the supervisor (e.g. assist other colleagues with laboratory investigations, training of other analysts as assigned.
QUALIFICATIONS: 3 ? 6 yrs relevant experience with Bachelor's Degree, 5+ yrs with Associate's Degree; Good working knowledge of dissolution and chromatographic techniques, especially HPLC, is necessary and a requirement. Working knowledge of both computer and/or data handling acquisition systems is necessary and required. Candidate must have good oral and written communication skills. cGMP experience is required. Previous pharmaceutical, quality control / stability experience preferred.