Location: Buena, NJ
The primary responsibility is to assess, monitor and improve the investigation, CAPA, and batch record review and release procedures at the Buena, New Jersey Facility.
- Work with all departments on the closure and content of investigations. This includes all types of investigations, OOS (Chemical and Microbiological), Manufacturing, Engineering, Technical Services, etc.
- Keep management updated on status of investigations and trends.
- Develop all employee skills on performing root cause analysis.
- Work with the QA staff to review and release batch records in a timely manner.
- Work with QA Lead to develop and monitor the In-Process Quality Assurance staff.
- Keep current with US FDA regulations and the impact on Teligent’s compliance.
- Work with the QA Staff to develop and mentor on Quality issues.
- Lead and support site specific audit readiness activities.
- Minimum of 5 years of experience in Quality Assurance and regulatory compliance in the pharmaceutical industry, preferably with generic pharmaceuticals.
- Bachelor’s degree in a science or technical discipline (Chemistry, Biology, Microbiology, Engineering)
- Minimum 2 years’ experience supervising personnel.
- Familiarity with FDA, ICH and UP requirements for multiple dosage forms, including topical, ophthalmic, injectable and complex drug forms; willingness and ability to develop knowledge in these areas as the business expands in scope and complexity.
- Able to manage shifting priorities and stay focused on long term goals and timelines.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs