503B Solid Dosage Manufacturing Operation Houston Texas
The Role: 503B Solid Dosage Manufacturing Operator
Location: Houston, Texas
HireBetter’s client is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. They hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.
The Solid Dosage Manufacturing Operator is responsible for executing all processes related to the manufacture of pelletized and cream/ointment products at our client 503B facility. Manufacturing personnel must adhere to 21 CFR parts 210/211 andUSP / regulations,current Good Manufacturing Practices (cGMP), and department’sStandard Operating Procedures (SOPs).
- Performs manufacturing in both a cGMP cleanroomenvironment (ISO 7, ISO 8) and a Controlled/Non-classified (CNC) non-sterile lab
- Manufactures product accurately and in compliance with master batch records while adhering to department specific SOPs
- Sets up, operates, and troubleshootsallequipmentutilized in the pelletizing (presses, deduster, weigh sorter, ampoule filler) and cream/ointment (mixers, ointment mill, pneumatic filler) manufacturing processes in order to deliver qualitymedication
- Operates equipment that utilizes oxygen and propane for flame control (glass-forming)
- Performs precise testing on final product during and after production
- Maintainsan ISO classified environment through rigorous cleaning and disinfecting of thecleanroomin accordance with approved procedures
- Performsessentialcalculations and completesthoroughdocumentation
- Methodically prepareswork area and supplies prior tomanufacturing
- Becomes trainedand qualifiedinSolid Dosage operation via internal trainingprogram
- Performsancillary tasks and duties that support themanufacturingprocess such as, but not limited to,material preparation, weight sorting, inventory accounting, and various LEAN manufacturingtasks(6S, GEMBA, Kaizen)
- Performsother duties and responsibilities within the department to ensuretimely execution of the productionschedule
- Ensuresall required hygienic practices andgarbing are performed per companypolicy
- Achieves “Gown Qualified” status within two attempts, allowing entry into the cleanroom
- Dons appropriate PPE, including full-face respirator, while in the powder processing area
- Observes and aids in coaching new hires on Solid Dosage operations
- Is dependable with attendance and ison timefor each shiftstart
- Provides overtime support, as needed, to maintain appropriate inventory levels
- Assists with special projects, as needed
- Other duties, as assigned
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. Employee must be ableto stand and walk for extended periods of time for consecutivedays. Employee must be able to lift up to 30 lbs.
- High School Diploma or equivalent required
- Blending, granulation, or compression knowledge and experience preferred
- Previous cGMP or LEAN manufacturing experience preferred
- Experience with operation of equipment and/or toolspreferred
- Ability to read, understand, follow, and comply with technical and written documents (SOPs)
- Detail-oriented and self-motivated
- Problem solver who enjoys collaborating with a team to resolve issues
- Works in a confined, controlled environment for extended periods of time(4 plus hours)
- Must be able to fully gown in cleanroom garb for extended periods oftime
- Must be able to work with hazardous substances (drugs) and work with strong odors (such as, but not limited to,peraceticacid)
- Communicates and collaborates effectively with a team to achieve goals around safety, quality, anddelivery
- Must be ableto perform rudimentary mathematical calculations
Interested candidates should apply through the HireBetter website at jobs.hirebetter.com. Qualified applicants will be responded to as quickly as possible.
Please note: Applicants for employment in the U.S. must possess work authorization that does not require sponsorship for a visa now or in the future.