Location: Buena, NJ
The primary responsibility is to work with all departments on developing investigation skills especially root cause analysis tools and assist in tracking and trending investigations and CAPA’s.
- 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.
- Keep current with US FDA regulations and the impact on Telligent’s compliance.
- Lead and support site specific audit readiness activities.
- Other duties as assigned.
- Bachelor’s degree in a science or technical discipline (Chemistry, Biology, Microbiology, Engineering) required.
- Minimum of 2 years of experience in Quality Assurance and regulatory compliance in the pharmaceutical industry, with sterile products.
- Familiarity with environmental and microbiological requirements for aseptic and terminally sterilized products
- 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.
- Excellent communication and leadership skills
- Strong knowledge of cGMP requirements.
- Proficient in Microsoft Word and Acrobat (PDF) documentation systems.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities.
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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