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 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 SummaryTheSterile 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 andUSP / regulations,current Good Manufacturing Practices (cGMP), and department'sStandard Operating Procedures (SOPs). Duties and Responsibilities
- Performs sterile manufacturing in a cGMP cleanroomenvironment (ISO 5, ISO 7, ISO 8).
- Manufacturessterile products accurately and in compliance with master batch records while adhering to department specific SOPs.
- Utilizes appropriate aseptic technique when performing tasks within the cleanroom.
- Operatesallfill-finish and ancillary manufacturing equipment in order to deliver qualitymedication.
- Maintainsan ISO classified environment through rigorous cleaning and disinfecting of thecleanroom in accordance with approved procedures.
- Assistswith sterilization of components used in themanufacturingprocess.
- Performsessential calculations and completesthoroughdocumentation.
- Methodically prepareswork area and supplies prior to manufacturing.
- Performs transfer of products from the cleanroom to the Inspection and Labeling team
- Becomes trainedand qualifiedin the Sterile operation via internal trainingprogram.
- Performsancillary tasks and duties that support themanufacturingprocess such as, but not limited to, autoclaving, bubble point testing, material preparation, inventory accounting,organization of components, and various LEAN manufacturingtasks(6S, GEMBA, Kaizen).
- Performsother duties and responsibilities within the department to ensure timely execution of the productionschedule.
- Ensuresall required hygienic practices and garbing are performed per companypolicy.
- Achieves Gown Qualified status within two attempts, allowing entry into the cleanroom.
- 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.
- 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 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.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. 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 oftime.
- Must be able to work with hazardous substances (drugs) and work with strong odors (such as, but not limited to,peraceticacid).
- Must be ableto perform rudimentary 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 other accountable to meet commitment.
- 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 equivalentrequired
- 1+ years previous manufacturing experiencepreferred.
- Previous cGMP or LEAN manufacturing experience preferred.
- Experience with operation of equipment and/or toolspreferred.
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.