Location: Buena, NJ
- 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 Teligent’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.
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.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
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.