Batch Record Reviewer 1st Shift
Company: ImprimisRx
Location: Ledgewood
Posted on: June 23, 2022
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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
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