503A Solid Dosage Manufacturing Operator Houston Texas
The Role: 503A 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 compounding medication into capsules or tablets via automated equipment, troches, and creams in a manual and/or machine-assisted fashion. The operation can take place in a cleanroom, Hazardous Non-Sterile Lab, or Non-Hazardous Non-Sterile Lab environment. The operation involves working with process equipment such as an automatic encapsulation machine, automatic and manual tablet press machines to make the product, and automated packaging machines to enclose the final product in a proper container.
Shifts 6:00am – 3:00pm and 9:00 – 6:00pm
- Performs compounding calculations and complete documentation adhering to GMP – Good Documentation Practices & ALCOA principles
- Learns the entire manufacturing operation via an internal training program
- Compounds preparations accurately and in compliance with master formula worksheets following industry guidelines, company policies, current and approved Standard Operating Procedures, work instructions, and best practices on safety, quality, and manufacturing
- Loads and unloads machinery with raw materials and finished product
- Operate, troubleshoot, assemble, disassemble, and cleans equipment while ensuring employee safety, product quality and quantity
- Monitors all equipment’s performance to troubleshoot and report any issues and abnormal conditions
- Safely operates equipment that utilizes oxygen and propane for flame control (glass-forming)
- Understands and adjusts equipment based on mechanical properties/concepts such as weight, product deformation, hardness, friability, equipment operational issues
- Operates various packaging machines such as a blister packing machine or an ampoule filler/sealer
- Performs production in an ISO-classified, Hazardous, and Non-Sterile cGMP environment
- Becomes gown qualified
- Performs ancillary tasks and duties that support the manufacturing process such as, but not limited to, weight sorting, inventory accounting, packaging, and LEAN manufacturing (5S, RCCMs, GEMBA)
- Performs precise testing on the final product during and after production
- Documents activities in real-time on controlled documentation and legibly, per SOPs and cGMPs
- Records operational and production data on specified forms and spreadsheets observing GMP and ALCOA principles
- Complies with safety and quality industry regulations and maintains work areas and equipment clean and in order
- Maintains an ISO-classified environment through rigorous cleaning and disinfecting of the workspace and components according to USP regulations and company policies
- Ensures cleansing and garbing are performed per company policy
- Utilizes aseptic technique when performing tasks within the cleanroom
- Prepares work area and supplies thoroughly prior to production
- Performs other duties and responsibilities within the department to ensure the execution of the production schedule
- Assists in other duties as needed and directed
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
- Familiarity with handling tools and labware is required
- Experience disassembling and assembling equipment is required
- Pharmacy technician trainee or certification is required
- Experience in the Health care or pharmaceutical industries is preferred
- Blending, granulation, compression, and encapsulation experience is preferred
- Computer skills required (Microsoft Office 365 and basic computer user skillset)
- Ability to read, understand, follow, and comply with technical and written documents (SOPs and WIs)
- Problem solver who enjoys collaborating and teamwork
- Seeks out new opportunities for continuous learning and continuous improvements (Lean/Six Sigma Manufacturing, Kaizen, Gemba walk, among others)
- Must be able to follow detailed processing instructions as well as clearly and accurately document all necessary batch records
- Familiar with standard concepts, practices, and procedures within the pharmaceutical field (Compounding pharmacy)
- Able to lift up to 50 lbs. and stand most part of the shift
- Demonstrates reliability and consciousness
- Can perform in an ISO-classified cleanroom where the operator is fully gowned for most of the shift (restricted environment)
- Must be able to work in a hazardous drug setting wearing proper protective equipment
- Ability to work 5 day/8 hour shifts, and overtime as needed with minimal notice
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.