About ImprimisRx

At ImprimisRx, a wholly-owned company of Harrow Health, Inc., we are working hard to help our customers navigate the realities of the healthcare market by providing innovative medications that address both clinical and economic needs. To get there, we need exceptionally talented, bright, and driven people. If you would like to help us build a quality culture organization trusted by healthcare professionals from across the US, this is your chance to join us. We are looking for Compliance Investigation Specialist to join our manufacturing facility located in Ledgewood, NJ.

Job Summary

The Compliance Investigation Specialist is responsible for conducting/leading and writing investigation reports using different root cause analysis methodology to identify true root cause, suggesting and implementing appropriate corrective actions. To be successful in this position a person must have thorough understanding of the FDA GMP requirements, Pharmaceutical technical processes, a mindset of high standards for Quality, ability to express complex technical problems in simple, clear language, both verbally and in writing.

Position Responsibilities

• Leads complex investigations to determine root cause and determine potential product impact
• Gathering data from various sources across the site, performance of root cause analysis to determine the most likely cause of the deviation investigation assessment of event, perform trending analysis, identification of corrective and preventative actions to reduce deviation recurrence, performance of risk assessments, cause mapping, interviewing.
• Management of multiple investigations and timelines concurrently. Ability to adhere to standard timeline schedule and escalate actions appropriately for resolution in a timely manner. Participation in the daily management meetings to update manufacturing leadership on current deviation statuses.
• Routine interaction with the site management, including compilation of spreadsheets to communicate investigational status, deviation metrics, alignment meetings, facilitated investigation reviews, CAPA discussions, comments resolution.
• Work on the production floor for data gathering, observing of processes for investigations, and performance of associate interviews.
• Mentoring and training of manufacturing supervisors and shift leaders. Provide investigation guidance and expertise for complex deviation investigations to the team, as well as to associated cross functional teams in order to drive to root cause of the events.
• Perform other duties as assigned.

Requirements

• Associate or Bachelor’s degree in a scientific field.
• 3-5 years of extensive experience in the pharmaceutical industry, preferably in Product, Manufacturing with solid experience in writing and reviewing investigations.
• Excellent problem-solving skills
• Working knowledge of root cause analysis tools
• Excellent technical writing skills
• Expert knowledge of manufacturing operations
• Working knowledge of Microsoft Word, Excel, and PowerPoint is necessary

Position Type and Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 8am-4:30pm Occasional weekend and evening hours may be required.

AAP/EEO Statement

Imprimis believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically, with our employees, we focus on attracting, developing, and retaining the best talent for our business, challenging our people, demonstrating a “can-do” attitude and fostering a collaborative and mutually supportive environment.

Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to age, ancestry, race, color, religion, sex, national origin, protected veteran status, disability status, marital status, medical condition, genetic information, national origin, gender (including gender identity and expression), or sexual orientation.

ImprimisRx is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.