Solid Dosage Manufacturing Operator 503B

Company Overview

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We 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.

What sets us apart is our relentless focus on four core values: People, Quality, Service and Innovation. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you’ll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let’s revolutionize healthcare, together. Join us and be a part of something extraordinary.

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.
  
  

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, and comply with technical and written documents (SOPs).
• Detail-oriented and self-motivated.
• Must be able to perform fundamental mathematical calculations.
  
  

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
  
  

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.
  
  

Experience And Qualifications

• 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 such as presses, deduster, weigh sorter, ampoule filler and/or tools preferred.
  
  

Employee Benefits, Health, And Wellness

• No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
• Onsite Health & Wellness - IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
• Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
• Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
• Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
• Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
• Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
• FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
• 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
• Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
• Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
• Rewards & Recognition Program: Your hard work doesn't go unnoticed - enjoy rewards and recognition beyond your paycheck.
  
  

Additional Voluntary Benefits

• Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
• Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
• Critical Illness: Protect your finances from the expenses of a serious health issue.
• Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
• Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
• Legal Services: Access professional legal assistance to address concerns confidently.
• Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
• Pet Insurance: Care for your furry family members with our pet insurance coverage.
• Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.