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Solid Dosage Manufacturing Operator

4 months ago

Houston, United States Empower Pharmacy Full time

Position Summary:
At Empower, we are on a mission to revolutionize healthcare by creating innovative, high-quality medications that enhance people's lives. As a Solid Dosage Manufacturing Operator in Empower’s 503B outsourcing facility, you will be a vital part of this mission. This role offers an exciting opportunity to immerse yourself in the dynamic world of pharmaceutical manufacturing, working in cutting-edge cleanroom environments and controlled non-sterile labs.

As a key player in our manufacturing team, you will be responsible for producing a variety of solid dosage forms, ensuring they meet the highest standards of quality and safety. Your daily responsibilities will involve operating sophisticated equipment used in processes such as pelletizing as well as performing precise testing on the final product. With a focus on compliance, you will meticulously follow master batch records and standard operating procedures, contributing to our unwavering commitment to quality.

In this role, you will have the opportunity to engage in innovative LEAN manufacturing tasks. Your dedication to maintaining an ISO-classified environment through rigorous cleaning and disinfecting will be crucial in upholding our standards.

At Empower, we believe in fostering a supportive and collaborative work environment where every team member is valued. As a Solid Dosage Manufacturing Operator, you will play a significant role in our success, helping us achieve our vision of expanding access to quality, affordable medication. Join us and be part of a team that is making a tangible difference in people's lives while advancing your career in an exciting and dynamic industry.

Duties and Responsibilities:

- Performs manufacturing in both a cGMP cleanroom environment (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 troubleshoots all equipment utilized in the pelletizing and manufacturing processes to deliver quality medication.
- Operates equipment that utilizes oxygen and propane for flame control (glass-forming).
- Performs precise testing on final product during and after production.
- Maintains an ISO classified environment through rigorous cleaning and disinfecting of the cleanroom in accordance with approved procedures.
- Performs essential calculations and completes thorough documentation.
- Methodically prepares work area and supplies prior to manufacturing.
- Receives training and becomes qualified in Solid Dosage operation via internal training program.
- Performs ancillary tasks and duties that support the manufacturing process such as, but not limited to, material preparation, weight sorting, inventory accounting, 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.
- Dons appropriate PPE, including full-face respirator, while in the powder processing area.
- Observes and aids in coaching new hires on Solid Dosage operations.
- Consistent, dependable and on-time attendance for each shift.
- 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 regularly required to work in a confined, controlled environment for extended periods of time (up to 4 hours at a time without a break). This requires the employee to remain fully gowned in cleanroom garb for extended periods of time. Employee must be able to work with hazardous substances (drugs) and work with strong odors (such as, but not limited to, peracetic acid). 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. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Employee must be able to stand and walk for extended periods of time throughout their scheduled work week. Employee must be able to lift up to 30 lbs.

Knowledge and Skills:

- Ability to read, understand, follow