Batch Record Reviewer 1st Shift

Company: ImprimisRx
Location: Ledgewood
Posted on: June 23, 2022

Job Description:

Job Description About ImprimisRx ImprimisRx, a wholly-owned subsidiary of NASDAQ listed Harrow Health Inc., is one of the nations leading ophthalmology compounding businesses. ImprimisRx is headquartered in Carlsbad, CA and operates two production and dispensing facilities based in Ledgewood, New Jersey. ImprimisRxs 503B outsourcing facility produces formulations for office use in accordance with current good manufacturing practices (cGMP), the highest federal quality standards for drug manufacturers in the country. Its 503A pharmacy produces customizable, patient-specific formulations pursuant to a physician prescription for several chronic care needs. There have been over one million eyes served by the formulations produced at these facilities. Position Responsibilities: Must be able to review production batch records in a timely manner. Ensure sterile production batch documentation is accurate.Work closely with production to generate daily production analytical reporting.Review and author Standard Operating Procedures in a sterile manufacturing environment. Must be able to create and review logbooks for production. Monitoring of internal environmental monitoring system for the Production area. Trending of batch record errors for the purpose of driving continuous improvement.Providing a work environment that fosters positive energy, creativity, and teamwork.Provide feedback for continuous improvement. Other additional duties as assigned. Requirements and Qualifications:Must have experience in a CGMP regulated environment and have worked in a pharmaceutical, Biotechnology or medical device manufacturing facility.Ability and willingness to work and participate effectively in a team environment. Ability and willingness to maintain accurate and factual hard copy and electronic records.Attention to detail, safety, quality and customer requirements.Ability to effectively communicate verbally and in writing to peers and management.Ability to read information and apply what is described in the reading material to situations that may contain several details or describe processes involving several steps.Demonstrate high level of personal motivation and initiative. Position Type and Expected Hours of WorkThis is a full-time position. Days of work are Monday through Friday. Occasional weekend and evening hours may be required as per business needs.This position requires completion of on-the-job training for a 1-2 month period.Training Shift: 7:00AM - 3:30PM1st Shift: 5:00AM- 1:30PM Physical DemandsThese physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of the job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions.While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to sit and drive. The employee is also required to travel via airplane frequently, which involves sitting in an airplane for extended periods of time, lifting luggage or personal items and being comfortable with flying. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance. Vision abilities required by this job include close vision. Work EnvironmentWhile performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.While performing the duties of this job, the employee is frequently exposed to moving vehicles, traffic, pedestrians and typical environment one experiences while driving and traveling. The noise level in the work environment is usually quiet to moderate and is dependent on where the employee is conducting work, which will vary. AAP/EEO StatementImprimis 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.

Keywords: ImprimisRx, Newark , Batch Record Reviewer 1st Shift, Other , Ledgewood, New Jersey