18 Brentwood Ct
SUMMARY: Set up equipment/machines aseptically for proper operation, including installation and disassembly of equipment and parts required. Operate clean room machines aseptically and efficiently (Kalix ointment tube filler, Chase-Logeman bottle filler) Prepare filter wetting solution and bubble point test Hydrophilic and Hydrophobic filters for manufacturing Prepare, weigh and package raw materials (powder) for contract sterilization Make Isopropyl Alcohol 70%, Veshpene and LpH as disinfectants used in Aseptic Manufacturing Must disinfect, deliver and stock gowning components to the gowning room Maintain aseptic gowning qualification Follow aseptic gowning procedures. Perform reconciliations of components, drug products, and associated materials as per defined procedures. 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. Must assume any position required within the department for coverage. Cleaning and sanitization of the aseptic production areas, including filling room sanitization between runs. Must document sanitization activities in log books, forms etc. in a legible manner as per cGMP. Must be able to work until all cleaning activities are complete. Must be flexible in adapting to a work schedule that could change as a result in business direction. Must be detail oriented with the ability to work within a team environment or independent if required.
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.
Must coordinate with packaging dept. senior operators to ensure all production activities are performed and production demands are satisfied.
QUALIFICATIONS: High School Diploma or GED required; Associate s Degree preferred Previous experience in Pharmaceutical Manufacturing required Previous experience in an aseptic environment required - must be able to be gown-certified JOB PREREQUISITES: 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.* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE:
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