Sterile Production Technician

Imprimis Pharmaceuticals, Inc Ledgewood , NJ 07852

Posted 4 months ago

Title: Sterile Production Technician Status: Non-exempt

Reports to: Production Supervisor/Manager

About ImprimisRx

ImprimisRx is one of the nation's leading ophthalmology compounding businesses ImprimisRx is headquartered in San Diego, CA and operates two production and dispensing facilities based in Ledgewood, New Jersey. ImprimisRx's 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.

Job Summary

All Production Line Operators are responsible for all activities associated with the manufacturing and filling operations, required to produce sterile drug products under aseptic conditions.

Responsibilities

  • Must be detail oriented with the ability to work within a team environment or independent if required.

  • Set up equipment/machines aseptically for proper operation, including installation and disassembly of equipment and parts required.

  • Operate clean room machines aseptically and efficiently (Flexicon30 semi bottle filler, Manual Bottle Filling and Vials filling in a LFH).

  • Prepare filter wetting solution and bubble point test Hydrophilic and Hydrophobic filters for manufacturing.

  • Sanitized clean room with Isopropyl Alcohol 70%, Vesphene as disinfectants used in Aseptic Manufacturing.

  • Must disinfect, deliver and stock gowning components to the gowning room

  • Maintain aseptic gowning qualification

  • Perform reconciliations of components, drug products, and associated materials as per defined procedures.

  • Follow aseptic gowning procedures.

  • Must be able to follow detail instructions in BR during compounding procedure.

  • Dispose of waste after filling process is finish: Weighing, recording and attaching data or records to Batch Record

  • Set up/preparation/cleaning and autoclaving components used in aseptic manufacturing operations. (Some lifting required, up to 55-60 lbs.) Any object greater than 60 pounds, not to exceed 100 lbs. must require the use of a buddy system. This system requires two employees to lift the object. No employee can lift any object greater than 60 lbs by themselves.

  • Some Saturdays and Sunday (Overtime) will be required to work by the company based on the department's schedule

Job Prerequisites:

  • Minimum of two years' experience in a pharmaceutical sterile production environment

  • Ability to meet attendance standards. All full-time employees are required to work a 40 hour week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.

  • Strong communication skills.

  • The ability to manage multiple operations, simultaneously during routine duties.

  • Must coordinate with packaging dept. senior operators to ensure all production activities are performed and production demands are satisfied.

Qualifications & Experience:

  • High School or Associate's Degree and equivalent job experience in Pharmaceutical Manufacturing.

  • Knowledge of drug development process, GMP/GLP manufacturing of active pharmaceutical ingredients and drug products and follows procedures effectively.

  • Experience in filling/formulation of manufacturing of sterile and non-sterile products

  • Demonstrated ability to work both independently and as part of a multidisciplinary team

Physical Demands

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 accommodation can be made to enable people with disabilities to perform the described essential functions.

While performing the duties of this job, the employee is regularly required to talk and hear. The ability to see distinctions in colors and shapes is also required. This position is moderately active and requires standing and walking for the duration of the shift. There is a high frequency of reaching over your head and bending down throughout the duration of each shift.

Work Environment

While 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.

This job operates in a production setting. This position requires frequent bending, walking, standing during manufacturing and filling of sterile compounds. While performing the duties of this role, the employee will be exposed to light, noise.

Position Type and Expected Hours of Work

It is a full-time position in a compounding pharmacy with regular operations occurring between M-F. Working hours may vary anywhere from several hours before opening to several hours after closing. Additionally, weekend hours may be needed depending upon workload demands. Rotating shifts, as well as holiday and work during inclement weather, may be required.

Travel

No travel is expected for this position.

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 race, color, religion, sex, national origin, protected veteran status, or disability status.

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.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time, with or without notice.


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VIEW JOBS 8/14/2019 12:00:00 AM 2019-11-12T00:00 Title: Sterile Production Technician Status: Non-exempt Reports to: Production Supervisor/Manager About ImprimisRx ImprimisRx is one of the nation's leading ophthalmology compounding businesses ImprimisRx is headquartered in San Diego, CA and operates two production and dispensing facilities based in Ledgewood, New Jersey. ImprimisRx's 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. Job Summary All Production Line Operators are responsible for all activities associated with the manufacturing and filling operations, required to produce sterile drug products under aseptic conditions. Responsibilities * Must be detail oriented with the ability to work within a team environment or independent if required. * Set up equipment/machines aseptically for proper operation, including installation and disassembly of equipment and parts required. * Operate clean room machines aseptically and efficiently (Flexicon30 semi bottle filler, Manual Bottle Filling and Vials filling in a LFH). * Prepare filter wetting solution and bubble point test Hydrophilic and Hydrophobic filters for manufacturing. * Sanitized clean room with Isopropyl Alcohol 70%, Vesphene as disinfectants used in Aseptic Manufacturing. * Must disinfect, deliver and stock gowning components to the gowning room * Maintain aseptic gowning qualification * Perform reconciliations of components, drug products, and associated materials as per defined procedures. * Follow aseptic gowning procedures. * Must be able to follow detail instructions in BR during compounding procedure. * Dispose of waste after filling process is finish: Weighing, recording and attaching data or records to Batch Record * Set up/preparation/cleaning and autoclaving components used in aseptic manufacturing operations. (Some lifting required, up to 55-60 lbs.) Any object greater than 60 pounds, not to exceed 100 lbs. must require the use of a buddy system. This system requires two employees to lift the object. No employee can lift any object greater than 60 lbs by themselves. * Some Saturdays and Sunday (Overtime) will be required to work by the company based on the department's schedule Job Prerequisites: * Minimum of two years' experience in a pharmaceutical sterile production environment * Ability to meet attendance standards. All full-time employees are required to work a 40 hour week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines. * Strong communication skills. * The ability to manage multiple operations, simultaneously during routine duties. * Must coordinate with packaging dept. senior operators to ensure all production activities are performed and production demands are satisfied. Qualifications & Experience: * High School or Associate's Degree and equivalent job experience in Pharmaceutical Manufacturing. * Knowledge of drug development process, GMP/GLP manufacturing of active pharmaceutical ingredients and drug products and follows procedures effectively. * Experience in filling/formulation of manufacturing of sterile and non-sterile products * Demonstrated ability to work both independently and as part of a multidisciplinary team Physical Demands 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 accommodation can be made to enable people with disabilities to perform the described essential functions. While performing the duties of this job, the employee is regularly required to talk and hear. The ability to see distinctions in colors and shapes is also required. This position is moderately active and requires standing and walking for the duration of the shift. There is a high frequency of reaching over your head and bending down throughout the duration of each shift. Work Environment While 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. This job operates in a production setting. This position requires frequent bending, walking, standing during manufacturing and filling of sterile compounds. While performing the duties of this role, the employee will be exposed to light, noise. Position Type and Expected Hours of Work It is a full-time position in a compounding pharmacy with regular operations occurring between M-F. Working hours may vary anywhere from several hours before opening to several hours after closing. 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In addition, employees in certain positions are subject to random drug testing. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time, with or without notice. Harrow Health, Inc. Ledgewood NJ

Sterile Production Technician

Imprimis Pharmaceuticals, Inc