Sterile Manufacturing Operator

Empower Pharmacy; Houston (TX); On-site; USD 35,000 - 50,000; Full time

Job summary

Empower Pharmacy, a leader in compounding pharmacy, seeks a Sterile Manufacturing Operator in Houston. In this role, you'll ensure compliance with strict manufacturing standards in a cleanroom environment, contributing to the production of personalized pharmaceuticals. Join a dedicated team aiming to improve the quality of life for patients across the country.

Benefits

Health/Vision/Dental Insurance

401k with company matching

Paid Time Off (PTO)

Volunteer Time Off (VTO)

Paid Holidays

Qualifications

• 1+ years previous manufacturing experience preferred.
• Experience with cGMP or LEAN manufacturing preferred.
• Ability to work with hazardous substances.

Responsibilities

• Performs sterile manufacturing in a cGMP cleanroom environment.
• Operates fill-finish and ancillary manufacturing equipment.
• Maintains cleanroom environment and performs essential calculations.

Skills

Detail-oriented

Problem solving

Team collaboration

Education

High School Diploma or equivalent

Tools

Manufacturing equipment

Job description

Empower Pharmacy and Empower Pharma are the country's most advanced compounding pharmacy and FDA-registered outsourcing facility, providing pharmacies, healthcare practitioners and patients with personalized pharmaceuticals in the integrative health and wellness market. We currently serve more than 3.5 million patients across the United States.

With facilities that tout the latest automated pharmaceutical manufacturing equipment, cleanrooms, environmental controls and professional staff, we are proud of our leadership in the compounding industry. How we work is just as important as the work we do. We know that the basis of a great company is our people. Our diverse culture is the foundation for our growing company’s broader perspective: to serve the needs of our patients through innovation.

We are always seeking new ways to advance the manufacture and distribution of quality-of-life products through cutting-edge processes and technology. Our vision to be the leader in compounding never wavers. With modern, streamlined systems, state-of-the-art facilities and a dedicated team, we strive to deliver access to quality, affordable medication for patients across the country.

Company Overview

Empower Pharmacy and Empower Pharma are the country's most advanced compounding pharmacy and FDA-registered outsourcing facility, providing pharmacies, healthcare practitioners and patients with personalized pharmaceuticals in the integrative health and wellness market. We currently serve more than 3.5 million patients across the United States.

With facilities that tout the latest automated pharmaceutical manufacturing equipment, cleanrooms, environmental controls and professional staff, we are proud of our leadership in the compounding industry. How we work is just as important as the work we do. We know that the basis of a great company is our people. Our diverse culture is the foundation for our growing company’s broader perspective: to serve the needs of our patients through innovation.

We are always seeking new ways to advance the manufacture and distribution of quality-of-life products through cutting-edge processes and technology. Our vision to be the leader in compounding never wavers. With modern, streamlined systems, state-of-the-art facilities and a dedicated team, we strive to deliver access to quality, affordable medication for patients across the country.

Position Summary

The Sterile Manufacturing Operator (SMO) is responsible for executing all processes related to the manufacture of sterile product at Empower’s 503B facility. Manufacturing personnel must adhere to 21 CFR parts 210/211 and USP / regulations, current Good Manufacturing Practices (cGMP), and department’s Standard Operating Procedures (SOPs).

Duties and Responsibilities

• Performs sterile manufacturing in a cGMP cleanroom environment (ISO 5, ISO 7, ISO 8)
• Manufactures sterile product accurately and in compliance with master batch records while adhering to department specific SOPs
• Utilizes appropriate aseptic technique when performing tasks within the cleanroom
• Operates all fill-finish and ancillary manufacturing equipment in order to deliver quality medication
• Maintains an ISO classified environment through rigorous cleaning and disinfecting of the cleanroom in accordance to approved procedures
• Assists with sterilization of components used in the manufacturing process
• Performs essential calculations and completes thorough documentation
• Methodically prepares work area and supplies prior to manufacturing
• Performs transfer of products from the cleanroom to the Inspection and Labeling team
• Becomes trained and qualified in the sterile operation via internal training program
• Performs ancillary tasks and duties that support the manufacturing process such as, but not limited to, autoclaving, bubble point testing, material preparation, inventory accounting, organization of components, and various LEAN manufacturing tasks (6S, GEMBA, Kaizen)
• Performs other duties and responsibilities within the department to ensure timely execution of the production schedule
• Ensures all required hygienic practices and garbing are performed per company policy
• Achieves “Gown Qualified” status within two attempts, allowing entry into the cleanroom
• Observes and aids in coaching new hires on sterile operations
• Is dependable with attendance and is on-time for each shift start
• Provides overtime support, as needed, to maintain appropriate inventory levels
• Assist 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 able to stand and walk for extended periods of time for consecutive days.

Knowledge and Skills

• Ability to read, understand, follow , and comply with technical and written documents (SOPs) as well as detailed oral instructions
• Detail-oriented and self-motivated
• Problem solver who enjoys collaborating with a team to resolve issues
• Work in a confined, controlled environment for extended periods of time (4 plus hours)
• Must be able to fully gown in aseptic garb for extended periods of time
• Must be able to work with hazardous substances (drugs) and work with strong odors (such as , but not limited to, peracetic acid)
• Communicate and collaborate effectively with a team to achieve goals around safety, quality, and delivery
• Must be able to perform rudimentary mathematical calculations

Experience and Qualifications

• High School Diploma or equivalent required
• 1+ years p revious manufacturing experience preferred
• Previous cGMP or LEAN manufacturing experience preferred
• Experience with operation of equipment and/or tools preferred

Benefits

• Health/Vision/Dental Insurance
• 401k with company matching
• Paid Time Off (PTO)
• Volunteer Time Off (VTO)
• Paid Holidays

• High School Diploma or equivalent required
• 1+ years p revious manufacturing experience preferred
• Previous cGMP or LEAN manufacturing experience preferred
• Experience with operation of equipment and/or tools preferred

• Ability to read, understand, follow , and comply with technical and written documents (SOPs) as well as detailed oral instructions
• Detail-oriented and self-motivated
• Problem solver who enjoys collaborating with a team to resolve issues
• Work in a confined, controlled environment for extended periods of time (4 plus hours)
• Must be able to fully gown in aseptic garb for extended periods of time
• Must be able to work with hazardous substances (drugs) and work with strong odors (such as , but not limited to, peracetic acid)
• Communicate and collaborate effectively with a team to achieve goals around safety, quality, and delivery
• Must be able to perform rudimentary mathematical calculations

About the company

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