Company OverviewEmpower 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 three core values: People, Quality and Service. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and qualitycontrol, 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 SummaryAt Empower, the role of a Sterile Manufacturing Operator (SMO) is pivotal in ensuring the production of high-quality, sterile medications that our customers rely on for their health and well-being. This position embodies our core values of people, service, quality, and innovation. As a key player in our manufacturing team, you will be working in a state-of-the-art cleanroom environment, adhering to the highest standards of current Good Manufacturing Practices (cGMP) and International Organization of Standardization (ISO) classifications. In this dynamic role, you will utilize precise aseptic techniques and operate sophisticated fill-finish and ancillary manufacturing equipment. Your commitment to accuracy and compliance ensures the production of safe and effective medications. Maintaining the integrity of our cleanroom environment through rigorous cleaning and disinfecting procedures, and assisting with the sterilization of components, are vital responsibilities and ensures adherence to all hygienic practices which are essential to maintaining the highest standards of quality and safety in our operations.We invite you to join Empower and be a part of a team dedicated to producing innovative medications that help people live healthier, happier lives. Apply today to embark on a rewarding career with a company committed to excellence and innovation in healthcare. You will directly contribute to our mission of expanding access to quality, affordable medication and making a positive impact on the communities we serve. Duties and Responsibilities
- Executes processes related to the manufacture of sterile products in a cGMP cleanroom environment (ISO 5, ISO 7, ISO 8).
- Manufactures sterile products accurately and in compliance with master batch records while adhering to department specific Standard Operating Procedures (SOPs).
- Adheres to 21 Code of Federal Regulations parts 210/211 and United States Pharmacopeia / regulations, cGMP, and department's 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 with 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.
- Observes and aids in coaching new hires on Sterile operations.
- Provides overtime support, as needed, to maintain appropriate inventory levels.
- Assist with special projects, as needed.
- Performs other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential function satisfactorily while following good clean room behavior procedures. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations 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. Employee must be able to fully gown in aseptic garb and work in a confined, controlled environment for extended periods of time (up to 4-6 hours). Employee will work with hazardous substances (drugs) and strong odors (such as, but not limited to, peracetic acid). 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. Employee must be able to lift up to 50 lbs. Knowledge and Skills
- Ability to 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.
- Ability to add, subtract, multiply and divide.
- Ability to achieve Gown Qualified status within two attempts, allowing entry into the cleanroom.
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.
Experience and Qualifications
- High School Diploma or equivalent required
- 1+ years previous manufacturing experience preferred.
- Previous cGMP or Lean manufacturing experience preferred.
- Experience with operation of equipment 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.